Category

News
The FDA issued a final guidance entitled “Deciding When to Submit a 510(k) for a Software Change to an Existing Device)” dated October 25, 2017. This guidance clarifies for the industry how to determine which software changes to a 510(k)-cleared device require a new 510(k). It seems to reflect what the FDA has applied in...
Read More
Company: Sight Diagnostics LTD Date of Enforcement Report: 7/27/2022 Class II PRODUCT Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 Recall Number: Z-1469-2022 REASON The default reference ranges for MCH, MCHC, and RDW for age group “Child 2-11y” are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due...
Read More
Recently, a new cybersecurity standard, IEC 81001-5-1:2021, Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle, was released.  As the name implies, this standard addresses the overall software development lifecycle (SDLC) with regard to cybersecurity activities.  For medical device manufacturers, this is very...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 7/25/2022 Class II PRODUCT Centricity PACS Software Version 7.0 SP0.0.4.7 Recall Number: Z-1466-2022 REASON The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC VOLUME OF PRODUCT IN COMMERCE 47 installations...
Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: 7/22/2022 Class I PRODUCT ABACUS TPN (Total Parenteral Nutrition) Calculation software Recall Number: Z-1376-2022 REASON There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation. Voluntary. Firm Initiated. VOLUME OF PRODUCT IN COMMERCE 9 units...
Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: June 22, 2022 Class: I PRODUCT Abacus Order Entry and Calculation Software Recall Number: Z-1376-2022   REASON There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation VOLUME OF PRODUCT IN COMMERCE 9 units DISTRIBUTION...
Read More
Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report: 7/21/2022 Class II PRODUCT Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561 Recall Number: Z-1452-2022 REASON Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication...
Read More
FDA is requesting input on patient safety, including best practices to promote patient safety, education, and competency, associated with Non-Medical Device Software – software excluded from the medical device definition by the 21st Century Cures Act.  Software professionals should take this opportunity to explain the risks associated with non-medical device software interacting with medical device...
Read More
Company: Becton, Dickinson and Company Date of Enforcement Report: 6/22/2022 Product: Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered Drivers Reason: Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries Recalling Firm/Manufactuer: BD (Becton, Dickinson and Company) on 6/22/2022. Voluntary:...
Read More
Company: Dynex Technologies, Inc. Date of Enforcement Report: 7/5/2020 Class II PRODUCT DYNEX Agility, Agility Analyzer, Model No. 67000 Recall Number: Z-1222-2022 REASON Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay’s SmartKit will...
Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: 6/30/2022 Class II PRODUCT NaviCare Nurse Call/Voalte Nurse Ca Recall Number: Z-1306-2022 REASON An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call...
Read More
Company: Haemonetics Corporation Date of Enforcement Report: 6/28/2022 Class II PRODUCT Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay – PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using...
Read More
The Markup, a nonprofit newsroom that investigates how powerful institutions are using technology to change our society, reports that Facebook has been collecting patients’ sensitive health information—including details about their medical conditions, prescriptions, and doctor’s appointments—and sending it to Facebook.  They found that 33 of Newsweek’s top 100 hospitals in America contained a tracker, called the...
Read More
FDA will host a webinar to discuss Cybersecurity quality system considerations on Tuesday, June 14, 2022, from 1 p.m. to 2:15 p.m. EDT.  The webinar will focus on the latest and current Cybersecurity Premarket Submissions draft guidance released in April 2022.  This draft guidance replaces the 2018 draft version and is intended to further emphasize the...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 6/6/2022 Class II PRODUCT Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620 Recall Number: Z-1243-2022 REASON Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a...
Read More
Company: Bio-Rad Labratories, Inc. Date of Enforcement Report: 5/28/2022 Class II PRODUCT Sickle Cell Program Resin CD-ROM Recall Number: Z-1208-2022 REASON The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific...
Read More
Company: bioMerieux, Inc. Date of Enforcement Report: 5/25/2022 Class II PRODUCT VITEK 2 automated system. Recall Number: V-0141-2022 REASON Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests to not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results...
Read More
Company: Daavlin Distributing Company Date of Enforcement Report: 5/18/2022 Class II PRODUCT 1 Series CX phototherapy units equipped with Daavlin’s ClearLink Control System software versions v3.03h and 3.04v. Models: 1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6 1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5 1 Ser CX 311-4 120-240V 50/60Hz, item...
Read More
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 5/11/2022 Class II PRODUCT Azurion systems with software release R1.x Recall Number: Z-0886-2022 REASON In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the...
Read More
Company: DePuy Orthopaedics, Inc. Date of Enforcement Report: 5/11/2022 Class II PRODUCT VELYS Robotic-Assisted Solution Base Product No.: 451570100 Recall Number: Z-1029-2022 REASON System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause...
Read More
Company: Becton Dickinson & Co. Date of Enforcement Report: 5/11/2022 Class II PRODUCT BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10 Recall Number: Z-1018-2022 REASON When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes. RECALLING...
Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 5/4/2022 Class II PRODUCT MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x “My Therapy” Patient...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/27/2022 Class II PRODUCT SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/27/2022 Class II PRODUCT Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600 Recall Number: Z-0985-2022 REASON Five potential software issues affecting Artis pheno and Artis icono systems...
Read More
Company: Medtronic Xomed, Inc. Date of Enforcement Report: 4/27/2022 Class II PRODUCT Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300 Recall Number: Z-0961-2022 REASON As a result of Medtronic’s integrated power console...
Read More
Company: St. Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report: 4/27/2022 Class II PRODUCT Merlin PCS 3650 programmer Model 3330 software Recall Number: Z-0964-2022 REASON Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the...
Read More
Company: SIGHT DIAGNOSTICS LTD Date of Enforcement Report: 4/27/2022 Class II PRODUCT The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated...
Read More
Company: Varian Medical Systems Imaging Laboratory GmbH Date of Enforcement Report: 4/20/2022 Class II PRODUCT ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 Recall Number: Z-0942-2022 REASON Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location. RECALLING...
Read More
FDA has released a new draft of Premarket Cybersecurity in Medical Devices:  Quality System Considerations and Content of Premarket Submissions.  Per the scope, this 2022 FDA Premarket Cybersecurity Guidance “is applicable to devices that contain software (including firmware) or programmable logic, as well as software as a medical device (SaMD). The guidance is not limited to devices...
Read More
Company: Remote Diagnostic Technologies Ltd. Date of Enforcement Report: 4/13/2022 Class II PRODUCT Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 Recall Number: Z-0861-2022 REASON Distribution of Defibrillators that are not approved or cleared for distribution US Market. RECALLING FIRM/MANUFACTURER Remote Diagnostic Technologies Ltd. on 1/28/2022. Voluntary: Firm initiated VOLUME...
Read More
Company: Diagnos Inc. Date of Enforcement Report: 4/6/2022 Class II PRODUCT CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Recall Number: Z-0826-2022 REASON Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version. RECALLING FIRM/MANUFACTURER Diagnos Inc....
Read More
Company: InfuTronix LLC Date of Enforcement Report: 4/6/2022 Class II PRODUCT Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP Recall Number: Z-0832-2022 REASON An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/6/2022 Class II PRODUCT Ysio system with VC10 software version, Model Number 10281013. Radiographic system Recall Number: Z-0841-2022 REASON Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for...
Read More
New Date! COURSE DATES: May 9 – 12, 2022 (16 hours of training) HOURS:  11 am until 3 pm EDT each day TRAINING LOCATION: Virtual – live online COST: 4 half days for $1,920 per person Registration Link:  https://events.eventzilla.net/e/2022-softwarecpr-agile-and-compliant-training-course-2138816565 Only a limited number of discounted seats are available.  For more information on the course, use...
Read More
Company: Philips Healthcare Date of Enforcement Report: 3/30/2022 Class II PRODUCT Azurion systems with software release R2.0.x Recall Number: Z-0734-2022 REASON In the Azurion system, the user can add a new study to a patient by selecting the option “Add Study”. The Add Study dialogue box is then displayed where the Patient Type is selected...
Read More
Company: Abbott Laboratories, Inc Date of Enforcement Report: 3/23/2022 Class II PRODUCT Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and...
Read More
Company: Brainlab AG Date of Enforcement Report: 3/16/2022 Class II PRODUCT ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST. Recall Number: Z-0733-2022 REASON The yaw angle may be incorrect...
Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 3/16/2022 Class II PRODUCT RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks:...
Read More
Company: Stryker Corporation Date of Enforcement Report: 3/16/2022 Class II PRODUCT 1688 Camera Control Unit (CCU), Catalog number: 1688010000 1688 Pendulum Camera Heads Recall Number: Z-0728-2022 REASON A software defect has been identified in the 1688 Camera Control Unit (CCU) that will cause the image on the monitor to flip upside-down into an incorrect orientation....
Read More
IEC 62304 and Emerging Standards for Medical Device and Health IT Software DATES:  June 6-10, 2022 (New date) Clock time each day:  10 am – 3 pm US EDT (one hour break from 12:00 pm to 1:00 pm US Eastern time) COST: 5 short days for $2,200.00 – Multi-student discount available for 3 or more students...
Read More
The U.S. FDA updated the medical device report data files, posting the Patient Problem Codes associated with “legacy Alternative Summary Report (ASR) files” on https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files?utm_medium=email&utm_source=govdelivery. This update follows the addition of Patient Problem Codes to the public Manufacturer and User Facility Device Experience (MAUDE) database in September 2020 to provide additional information on the nature...
Read More
Company: Abiomed, Inc. Date of Enforcement Report: 2/9/2022 Class I PRODUCT OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall. Recall Number: Z-0550-2022 REASON...
Read More
Company: Philips North America LLC Date of Enforcement Report: 2/9/2022 Class II PRODUCT A software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager...
Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 2/9/2022 Class II PRODUCT ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B Recall Number: Z-0547-2022 REASON Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of...
Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 2/2/2022 Class II PRODUCT Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 Recall Number: Z-0515-2022 REASON Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No...
Read More
Company: Konica Minolta Healthcare Americas, Inc. Date of Enforcement Report: 1/26/2022 Class II PRODUCT ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC Recall Number: Z-0500-2022 REASON lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential...
Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 1/26/2022 Class II PRODUCT 1. Sensis, material # 10764561; UDI : 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 Recall Number: Z-0515-2022 REASON Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe...
Read More
Company: Ion Beam Applications S.A. Date of Enforcement Report: 1/19/2022 Class II PRODUCT Proteus 235; Version: PTS-8 versions before PTS-8.7.2 Recall Number: Z-0466-2022 REASON Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 1/19/2022 Class II PRODUCT SOMATOM Confidence – Computed tomography systems Model: 10590100 Recall Number: Z-0472-2022 SOMATOM Definition AS-Computed tomography system Model 8098027 Recall Number: Z-0473-2022 SOMATOM Edge Plus-Computed tomography system Model 1026700 Recall Number: Z-0474-2022 SOMATOM Definition Edge -Computed tomography system Model 10590000 Recall Number:...
Read More
1 2 3 89

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact training@softwarecpr.com

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.