Category

News
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
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
1 2 3 4 5 80

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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