You may have experienced the concept of diffusion of responsibility – when members of a group feel less personal obligation to perform an activity or task, assuming “someone else will handle it,” leading to inaction, delays, or reduced accountability. This can occur when the quality management system either poorly defines responsibility or defines responsibility to...Read More

Company: ICU Medical, Inc. Date of Enforcement Report: 12/19/2025 Class: II PRODUCT LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 Recall Number: Z-0966-2026 REASON: Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 12/19/2025 Class: II PRODUCT BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro...Read More

Company: Abbott Laboratories Date of Enforcement Report: 12/18/2025 Class: II PRODUCT Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 Recall Number: Z-0961-2026 REASON: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay analyzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software...Read More

Company: DICOM Grid, Inc. Date of Enforcement Report: 12/18/2025 Class: II PRODUCT Intelerad InteleShare software, with ProViewer component Recall Number: Z-0941-2026 REASON: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied,...Read More

Company: Medtronic MiniMed, Inc. Date of Enforcement Report: 12/18/2025 Class: II PRODUCT InPen App, Model/CFN Number: MMT-8061 (Android Users) Recall Number: Z-0958-2026 REASON: When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can’t choose to allow notifications to override phone settings when...Read More

Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report: 12/17/2025 Class: II PRODUCT 5008X CAREsystem +CLiC +CDX; Recall Number: Z-0936-2026 REASON: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled. RECALLING FIRM/MANUFACTURER: Fresenius Medical Care Holdings, Inc....Read More

Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 12/16/2025 Class: I PRODUCT Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients. Recall Number: Z-0885-2026 REASON: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. RECALLING FIRM/MANUFACTURER: Z-0885-2026 VOLUME:...Read More

Company: GE Healthcare GmbH Date of Enforcement Report: 12/16/2025 Class: II PRODUCT GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system Recall Number: Z-0935-2026 REASON: GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information. RECALLING...Read More

SoftwareCPR is planning a series of training courses in Kuala Lumpur, Malaysia (for Malaysian citizens). Our instructors understand regulatory agency expectations, including US FDA and EU,  and can train your staff accordingly and coach them on how best to articulate and defend your approaches in FDA and international standards terminologies. Our instructors have been in...Read More

Our ISO 13485 Internal Audit Training Course focuses on both the requirements of ISO 13485:2016 and the audit process and methods (ISO 19011) to ensure the manufacturer or supplier is compliant with the requirements of the standard. Our approach is to educate on the intent and purpose of the standard so that the participants are able...Read More

Company: Abbott Laboratories Date of Enforcement Report: 11/12/2025 Class: II PRODUCT: Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No Recall Number: Z-0489-2026 REASON: Software issue for hq analyzer results in...Read More

We understand the tension. You get it … we all want to be process focused. Create and maintain a good process, and good outputs will come forth. But you may be the one that faces the auditor or faces the inspector. They ask for evidence that the process was performed. You think, “life would be...Read More

The international standard, ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, provides the framework of the set of interrelated processes that work to ensure product quality.  This international standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be...Read More

Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: 11/5/2025 Class: I PRODUCT: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient...Read More

Company: Dexcom, Inc. Date of Enforcement Report: 10/30/2025 Class: I PRODUCT: Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 10/30/2025 Class: II PRODUCT: CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. Recall Number: Z-0412-2026 REASON: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device...Read More

Company: Vantive US Healthcare LLC Date of Enforcement Report: 10/29/2025 Class: II PRODUCT Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM) Recall Number: Z-0409-2026 REASON: Vantive has identified a software defect within the Sharesource Claria software, which may...Read More

Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: 10/23/2025 Class: II PRODUCT t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 10/10/2025 Class: I PRODUCT ACCOLADE SR SL (Model L300) Recall Number: Z-0079-2026 REASON: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes...Read More

Company: Bard Peripheral Vascular Inc Date of Enforcement Report: 9/26/2025 Class: II PRODUCT Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment...Read More

(Sep 13, 2025) FDA announces their 2025 Digital Health Advisory Committee Meeting On November 6, 2025, the FDA Digital Health Advisory Committee will discuss and make recommendations on the topic of generative artificial intelligence-enabled digital mental health medical devices. The Committee will discuss the benefits, risks to health, and risk mitigations that might be considered...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 9/16/2025 Class: II PRODUCT Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0...Read More

Company: Philips Medical Systems Nederland B.V. Date of Enforcement Report: 9/9/2025 Class: II PRODUCT IntelliSpace Cardiovascular, Software 8.0.0.4. Recall Number: Z-2543-2025 REASON: Software issue that results in the display of outdated information. RECALLING FIRM/MANUFACTURER: Philips Medical Systems Nederland B.V. QUANTITY: 4 units DISTRIBUTION: US Nationwide distribution in the states of GA, NC & TX.Read More

Company: Dexcom, Inc Date of Enforcement Report: 9/4/2025 Class: I PRODUCT Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitoring System Recall Number: Z-2446-2025 REASON: The...Read More