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

Company: GE Healthcare, LLC Date of Enforcement Report: 12/19/2018 Class II PRODUCT Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect. Recall Number: Z-0641-2019 REASON Issue #1 affects Software Versions 6.0 SP7,...Read More

Company: ICU Medical Inc Date of Enforcement Report: 12/17/2018 Class II PRODUCT SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient’s epidural space. Sets are intended for use with Sapphire Infusion Systems. Recall Number:...Read More

Company: bioMerieux, Inc. Date of Enforcement Report: 12/19/2018 Class II PRODUCT VITEK 2 Systems Software Version 9.01 Update Kit. Recall Number: Z-0639-2019 REASON The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP” feature. RECALLING...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 12/20/18 Class II PRODUCT VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid. Recall Number: Z-0651-2019...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 12/20/18 Class II PRODUCT VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Recall Number:...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report: 12/14/2018 Class II PRODUCT Xper Flex Cardio Physiomonitoring System Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 Recall Number: Z-0614-2019 REASON There are 3 issues: Under certain conditions, real time waveforms may not be accurately plotted or displayed. The...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 12/14/2018 Class II PRODUCT Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Recall Number: Z-0616-2019 (Vista 500, Model...Read More

Company: Tosoh Bioscience Inc Date of Enforcement Report: 12/14/2018 Class II PRODUCT AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the...Read More

Company: COVIDIEN LLC Date of Enforcement Report: 12/18/2018 Class I PRODUCT Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett” 980 Pediatric Adult Ventilator Puritan Bennett” 980 Neonatal Ventilator Puritan Bennett” 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who...Read More

Here are some quick links to websites that list the harmonised standards for the different directives.Read More

FDA posted a Medtronic announcement today that the company is launching a voluntary field action (VFA) for a software update on Puritan Bennett 980 Ventilators. The voluntary field corrective action is a software update to address customer feedback. The software updates the external USB Drive performance and its impact on Graphical User Interface (GUI) functionality...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

The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. Recognizing the opportunities for increased use of digital...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: Reagent Lock may...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 some terms (e.g. Cybersecurity Bill of Material) and concepts (e.g., Tier 1 and Tier 2 risks) that is important for manufacturers to understand and address in premarket submissions. It also includes labeling recommendations 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

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

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

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