Category

News
COURSE DATES: February 18 – 19, 2019 TRAINING LOCATION: Tampa, Florida, USA COST: 2 Full Days for $2,495.00 January Registration Discount of 10% available through Jan 19, 2018. Meet our newest partner, John Murray, at the course! Download registration form Only a limited number of discounted seats are available – download registration form and email...
Read More
It’s nice to have medical device FDA regulations and guidance accessible without navigating through old websites or lugging printed copies around. Thankfully, SoftwareCPR’s free iOs and Android apps allow you to quickly view medical device regulations and guidance on your smartphone offline! As medical device consultants, we know from experience how important it is to...
Read More
(January 7, 2019)— John F. Murray, Jr, of Mount Airy, MD USA, has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a partner. John retired from the US Food and Drug Administration in December 2018 after 32 years of federal service. For 25 years at FDA, John focused on FDA regulated software and...
Read More
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 12/29/2018 Class I: PRODUCT StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide – Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is...
Read More
Here are some quick links to websites that list the harmonised standards for the different directives.
Read More
Health Canada issued a draft guidance document titled, “Pre-market Requirements for Medical Device Cybersecurity.” Section 1.1 states: “Health Canada considers the inclusion of cybersecurity measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures which can improve the cybersecurity of...
Read More
FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018.  A few things to note related to software: On line 370, question 16, FDA addresses the question of the use of software...
Read More
FDA issued a report entitled “REPORT ON NON-DEVICE SOFTWARE FUNCTIONS: IMPACT TO HEALTH AND BEST PRACTICES – DECEMBER 2018.” This report contains findings on five software functions excluded from the device definition by the 21st Century Cures Act. The FDA found these software functions have more benefits than risks to patient safety and health. The...
Read More
FDA issued a draft guidance for prescription POC (Point-of-care) entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions for blood glucose monitoring systems used for diabetes management in the health care prescription POC settings. This guidance...
Read More
FDA issued a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use“‘. This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test systems used for diabetes management in the home setting. This guidance (similar to the Prescription POC guidance)...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 11/29/2018 Class II: PRODUCT Patient Monitoring System used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Recall Number: Z-0519-2019 (Dash 3000), Z-0520-2019 (Dash 4000), Z-0521-2019 (Dash 5000), Z-0522-2019 (Solar 8000i), Z-0523-2019 (Solar 8000M), Z-0524-2019 (Solar 9500) REASON The patient monitors may simultaneously restart as designed if all are connected...
Read More
Company: PerkinElmer Health Sciences Canada, Inc. Date of Enforcement Report: 11/28/2018 Class II: PRODUCT PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872 Recall Number: Z-0513-2019 REASON Under certain conditions...
Read More
Company: Synaptive Medical Inc. Date of Enforcement Report: 11/26/2018 Class II: PRODUCT BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only /...
Read More
Company: Beckman Coulter Life Sciences Date of Enforcement Report 11/20/2018 Class l: PRODUCT The FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers are used to simultaneously analyze multiple characteristics of thousands of individual cells in a relatively short period of time. These devices can be used to diagnose and monitor conditions, like blood cancers,...
Read More
Company: Tosoh Bioscience Inc Date of Enforcement Report: 11/19/2018 Class II: PRODUCT Tosoh AIA-900 immunoassay Analyzer Recall Number: Z-0485-2019 REASON A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later)...
Read More
Company: Voluntis Date of Enforcement Report: 11/16/2018 Class II: PRODUCT Insulia Diabetes Management Companion Recall Number: Z-0478-2019 REASON The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is...
Read More
The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting...
Read More
Company: Invivo Corporation Date of Enforcement Report: 11/14/2018 Class II: PRODUCT Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 Recall Number: Z-0462-2019 REASON The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 11/9/2018 Class II: PRODUCT Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X...
Read More
Company: Medtronic Inc. Date of Enforcement Report: 11/8/2018 Class II: PRODUCT Medtronic CareLink 2090 Programmer and Encore 29901 Programmer Recall Number: Z-0406-2019 (2090), Z-0407-2019 (29901) REASON Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download. RECALLING FIRM/MANUFACTURER Medtronic Inc.,...
Read More
For more information on this webinar click the link provided.
Read More
Bristol, UK. Now in its fifth year, the mission of the High Integrity Software conference is to share challenges, best practice and experience between software engineering practitioners. The conference features talks from industrial and academic specialists which disseminate experience and knowledge of important techniques and methods that are applicable across industry sectors. For more information...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 11/2/2018 Class II: PRODUCT Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources. Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources. Recall Number: Z-0374-2019 (5.0.x), Z-0375-2019 (6.0.x) REASON...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 10/24/2018 Class II: PRODUCT Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. Recall Number: Z-0195-2019 REASON Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI on...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 10/24/2018 Class II: PRODUCT Atellica Sample Handler Prime (SMN 11069001). The Atellica” Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. Recall Number: Z-0189-2019 REASON Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock...
Read More
Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 10/24/2018 Class II: PRODUCT Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 Recall Number: Z-0170-2019 REASON The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The...
Read More
FDA issued a draft guidance “Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices” dated 10/17/18. This document contains a some terms(e.g. Cybersecurity Bill of Materal) and concepts (e.g.,Tier 1 and Tier 2 risks) that it is important for Manufacturers to understand and address in premarket submissions. It also includes labeling recommenations for cybersecurity...
Read More
Company: AS Software, Inc Date of Enforcement Report 10/24/2018 Class II: PRODUCT AS-OBGYN Information System version 7.824.x Recall Number: Z-0118-2019 REASON Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that...
Read More
FDA announces a new pilot program to simplify certain 510(k)s. For more information on eligibility click the link and scroll to near the bottom of the page.  
Read More
Company: GE Medical Systems, LLC Date of Enforcement Report 8/24/2018 Class II: PRODUCT GE Healthcare MRI Systems, Software Version 11.x Recall Number: Z-0110-2019 REASON The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch. RECALLING...
Read More
This final guidance, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” replaces the 2013 draft guidance. This guidance focuses on clarifying and formalizing existing FDA practice including the requirement to submit FDA’s standards form for each standard used as well as discusses the use of obsolete standards. Originally standards were a...
Read More
Underwriters Laboratories, Inc. published the First Edition of the Standard for Safety for Remote Software Updates, UL 5500 on September 6, 2018. This standard covers remote software updates, accounting for the manufacturer’s recommended process to ensure safety. It is limited to software elements having an influence on safety and compliance with the particular end product...
Read More
Baxter Healthcare Corporation Date of Enforcement Report 10/24/2018 Class II: PRODUCT SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 Recall Number: Z-0107-2019 REASON If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a...
Read More
This SoftwareCPR.com newsletter in pdf form lists items added to the web site from early-June 2018 through mid-October 2018. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated...
Read More
Company: Agfa Healthcare NV Date of Enforcement Report 10/17/2018 Class II: PRODUCT Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as PACS Recall Number: Z-0101-2019 REASON Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the...
Read More
FDA released a final guidance "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications 510(k) with Different Technological Characteristics" dated Sept. 25, 2018.  This guidance applies only to devices with similar intended use and if the different technological characteristics do not raise different questions of Safety and Effectiveness.  Read the full guidance at...
Read More
The Australian medical device regulatory division TGA has release a new online tool to assist manufacturers with classifying their products.  The SME Assist tool “is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.”
Read More
Company: GE Healthcare Finland Oy Date of Enforcement Report 10/17/2018 Class II: PRODUCT GE Healthcare CARESCAPE Monitor B450 Recall Number: Z-0095-2019 REASON When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not...
Read More
Company: Synaptive Medical, Inc. Date of Enforcement Report: 10/9/2018 Class l: PRODUCT: Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration provides detailed three-dimensional (3D) images of a patient’s brain to help surgeons safely navigate surgical tools used during brain surgery. Recall Number: Z-0470-2019 REASON: Synaptive Medical has initiated this recall due to a software defect found in the BrightMatter...
Read More
FDA has posted their FY 2019 Proposed Guidance Development list with priorities. A link is provided below but here is the “A” list items: Final Guidance Topics Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions Unique Device Identification: Policy Regarding Compliance Dates for Class...
Read More
“Could this be a problem with the label printing software?” – Brian Pate Company: Smiths Medical ASD Inc. Date of Enforcement Report 10/10/2018 Class III: PRODUCT First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style Recall Number: Z-0071-2019 REASON “Manufactured” and “Use By” labels are transposed incorrectly suggesting the...
Read More
Medical devices within the EU are currently regulated by three Directives: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990) Council Directive 93/42/EEC on Medical Devices (MDD) (1993) Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)
Read More
Company: Vision RT Ltd Date of Enforcement Report 10/10/2018 Class II: PRODUCT Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only Recall Number: Z-0065-2019 REASON RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB RECALLING FIRM/MANUFACTURER Vision RT Ltd London, United Kingdom on 8/24/2018 Voluntary: Firm Initiated...
Read More
Company: Johnson & Johnson Surgical Vision Inc Date of Enforcement Report 10/10/2018 Class II: PRODUCT OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Recall Number: Z-0066-2019 REASON Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on...
Read More
Company: Oridion Medical 1987 Ltd.Date of Enforcement Report 10/10/2018 Class lI: PRODUCT Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 – 3.2, Product #: CS08651, CS08651-01, CS08651-01, CS08651-03, CS08657, CS08657-02 CS08657-01, CS08657-03, CS08653, CS08659, CS08750, CS08751, CS78651, CS78653CS78657, CS78659, CS08652, CS08652-01, CS08652-02, CS08652-03 CS08658, CS08658-01, CS08658-02, CS08658-03, CS08654, CS08654RA, CS08654RN, CS08660, CS08796, CS08798, CS08799,...
Read More
Company: Vision RT LtdDate of Enforcement Report 10/10/2018 Class lI: PRODUCT Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172 Recall Number:...
Read More
Company: Johnson & Johnson Surgical Vision Inc.Date of Enforcement Report 10/10/2018 Class lI: PRODUCT OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states “Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916;...
Read More
Datascope Corporation Product: drug manufacturing facility Date:9/11/18 Purchasing controls; complaint investigations 1. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm performed a supplier assessment from (b)(4) for Circulatory Technology and approved (“(b)(4)”) the use of...
Read More
Email: Industry.Biologics@fda.hhs.gov Phone: 240-402-8020 or 1-800-835-4709 After hours (after 4:30 pm EST weekdays, all day on weekends, and federal holidays) FDA Emergency Call Center, Phone: 866-300-4374 or 301-796-8240 What The MATTB Does CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide...
Read More
Quality in 510(k) “Quik” Review Program Pilot The Quality in 510(k) (“Quik”) Review Program provides an alternate method to submit a premarket notification (510(k)) to the FDA using the eSubmitter software to format the submission. The FDA has identified a list of product codes that are eligible for this pilot. These device types are moderate risk and are considered...
Read More
For more information on eligibility click the link. You can also download the current working model.
Read More
Company: Radiometer America Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or...
Read More
FDA Center for Biologics provides manufacturers with technical assistance. For email and phone contact information, and other information about this service, click the link.
Read More
Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.
Read More
October is National Cybersecurity Month; for more information from FDA click the link.
Read More
Vancouver, BC Canada . Focused on global regulatory affairs and harmonization. For more information click the link provided. RAPS Regulatory Convergence
Read More
Company: Varian Medical SystemsDate of Enforcement Report 10/3/2018 Class lI: PRODUCT TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated....
Read More
Company: Varian Medical SystemsDate of Enforcement Report 10/10/2018 Class lI: PRODUCT VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Recall Number: Z-0005-2019 REASON Reports have been received of...
Read More
Partner and General Manager Brian Pate will be one of the faculty for the AAMI Application of Agile Practices course in Arlington, VA USA.  John Murray of FDA is tentatively scheduled to join Brian as faculty.  For more information, send a message below:
Read More
Regulatory Requirements for Software Validation in the Medical Industry
Read More
IEC 80002-1 Software Risk Management for Medical Device and HealthIT
Read More
Effective Application of Agile Practices in the Development of Medical Device Software
Read More
Two webinars will be held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health Informatics, as well as the Member Bodies of ISO/TC 210, Quality management and corresponding general aspects for medical devices. These webinars are being held to explain the status of the IEC 62304 project. A committee...
Read More
Company: Boston Scientific CorporationDate of Enforcement Report 10/3/2018 Class lI: PRODUCT Model 3300 LATITUDE(TM) Programming System Product Usage – The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed...
Read More
Company: Medtronic Navigation, Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 – 3.2, Product #: 9735542 Recall Number: Z-3251-2018 REASON Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the...
Read More
Company: SwissrayDate of Enforcement Report 10/3/2018 Class lI: PRODUCT ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging Serial Numbers within U.S.A commerce – 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006,...
Read More
Company: Tosoh Bioscience Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT G8 Automated HPLC Analyzer – 723G8 Product Usage – In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in...
Read More
Philadelphia, PA: The MedTech Conference features senior level politicians and executives and a wide array of educational programming. For more information, click the link provided.  
Read More
Company: Stryker GmbH.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002 Recall Number: Z-3240-2018 REASON When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3,...
Read More
UL 5500 – Safety for Remote Software Updates has been adopted as a U.S. National Standard. It covers the remote updating of software via the manufacturer’s recommended process. It is limited to software elements having an influence on safety and on compliance with the particular end product safety standard. It is not specific for medical...
Read More
Company:Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report 9/26/2018 Class II: PRODUCT 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy Recall Number: Z-3194-2018 REASON In the hemodialysis machine during the cleaning/disinfection program,...
Read More
Company:Fresenius Medical Care Renal Therapies Group, LLC.Date of Enforcement Report 9/26/2018 Class lI: PRODUCT 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy. Recall Number: Z-3195-2018 REASON In the hemodialysis machine during the cleaning/disinfection program, when there...
Read More
Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 9/26/2018 Class lI: PRODUCT 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy Recall Number: Z-3194-2018 REASON In the hemodialysis machine during the cleaning/disinfection program, when...
Read More
Company:Mako Surgical Corporation Date of Enforcement Report 9/26/2018 Class lI: PRODUCT Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and...
Read More
Company:Mako Surgical CorporationDate of Enforcement Report 9/26/2018 Class lI: PRODUCT Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where...
Read More
Company:Mobius Imaging, LLC.. Date of Enforcement Report 9/26/2018 Class II: PRODUCT AIRO Mobile CT System Model # Mobi CT-32 Recall Number: Z-2991-2018 REASON The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is...
Read More
Company:Mobius Imaging, LLC..Date of Enforcement Report 9/26/2018 Class lI: PRODUCT AIRO Mobile CT System Model # Mobi CT-32 Recall Number: Z-2991-2018 REASON The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.....
Read More
For a quick and easy way to find US regulations, including those related to FDA, click the link provided.  
Read More
To search FDA MDRs, click the link provided.  
Read More
Company: Hitachi Healthcare Americas Corp Informatics Division. Date of Enforcement Report 9/12/2018 Class II: PRODUCT VidiStar(TM) PACS & DICOM Viewer Software system. Recall Number: Z-2992-2018 REASON The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study....
Read More
Company:Hitachi Healthcare Americas Corp Informatics Division.Date of Enforcement Report 9/12/2018 Class lI: PRODUCT VidiStar(TM) PACS & DICOM Viewer Software system. Recall Number: Z-2992-2018 REASON The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study. RECALLING FIRM/MANUFACTURER...
Read More
Company:Canon Medical System, USA, INC. Date of Enforcement Report 9/12/2018 Class II: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2964-2018 REASON It was found when an operator performs a radiography using the wireless flat panel detector...
Read More
Company:Canon Medical System, USA, INC.Date of Enforcement Report 9/12/2018 Class lI: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2964-2018 REASON It was found when an operator performs a radiography using the wireless flat panel detector (FPD),...
Read More
Company:McKesson Israel Ltd..Date of Enforcement Report 9/12/2018 Class lI: PRODUCT McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management,...
Read More
Company: Ortho Kinematics, Inc Date of Enforcement Report 8/29/2018 Class II: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2882-2018 REASON Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for...
Read More
Pharmaceutical Laboratories and Consultants, Inc. Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of...
Read More
Company: LIEBEL-FLARSHEIM COMPANY LLC Date of Enforcement Report: 8/29/2018 Class II: PRODUCT Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. Recall Number: Z-2833-2018 REASON Software issue....
Read More
Company: LIEBEL-FLARSHEIM COMPANY LLC Date of Enforcement Report 8/29/2018 Class II: PRODUCT Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.uch as functional x-ray diagnostics, endourology and minimal...
Read More
Pharmaceutical Laboratories and Consultants, Inc. Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of...
Read More
Pharmaceutical Laboratories and Consultants, Inc. Product: testing laboratory Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within...
Read More
Company: Spacelabs Healthcare, Ltd. Date of Enforcement Report 8/22/2018 Class II: PRODUCT Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. Recall Number: Z-2589-2018 REASON...
Read More
Company: McKesson Israel Ltd.. Date of Enforcement Report 9/12/2018 Class II: PRODUCT McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural...
Read More
Company:LIEBEL-FLARSHEIM COMPANY LLCDate of Enforcement Report 8/29/2018 Class lI: PRODUCT Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.uch as functional x-ray diagnostics, endourology and minimal invasive urology/...
Read More
Company:LIEBEL-FLARSHEIM COMPANY LLCDate of Enforcement Report 8/29/2018 Class lI: PRODUCT Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. Recall Number: Z-2833-2018 REASON Software issue. The difference...
Read More
Company:Ortho Kinematics, IncDate of Enforcement Report 8/29/2018 Class lI: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2882-2018 REASON Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral...
Read More
Company:Tosoh Bioscience Inc Date of Enforcement Report 8/22/2018 Class lI: PRODUCT NG8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This...
Read More
Company: Spacelabs Healthcare, Ltd Date of Enforcement Report 8/10/2018 Class I: PRODUCT The Arkon Anesthesia Delivery System is intended for use in hospitals and operating rooms. It may be used to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits (accessory sets that include tubing and breathing bags) with...
Read More
Yuki Gosei Kogyo Co., Ltd. Date:8/10/18 Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data. Your firm’s controls over your HPLC systems are inadequate. Some HPLC systems did not have audit trail capability or audit trails enabled....
Read More
Company:Spacelabs Healthcare, Ltd.Date of Enforcement Report 8/22/2018 Class lI: PRODUCT Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. Recall Number: Z-2589-2018 REASON Arkon Anesthesia...
Read More
1 2 3 39
Expand your access! Subscribe today!

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.