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 Recall Number: Z-2543-2025 REASON: Software issue that results in the display of outdated information.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

Company: mo-Vis BVBA Date of Enforcement Report: 9/2/2025 Class: I PRODUCT Micro Joystick R-net. Electrical wheelchair component. Recall Number: Z-2454-2025 REASON: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick...Read More

Company: Reflexion Medical, Inc. Date of Enforcement Report: 9/2/2025 Class: II PRODUCT RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is...Read More

Company: Medtronic MiniMed, Inc Date of Enforcement Report: 9/2/2025 Class: II PRODUCT InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) Recall Number: Z-2496-2025 REASON: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/29/2025 Class: I PRODUCT Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump Recall Number: Z-2332-2025 REASON: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 8/28/2025 Class: II PRODUCT BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis” MedStation” 4000 Main / 10885403512629 / 303 BD Pyxis” MedStation” ES Tower / 10885403512674 / 352 BD Pyxis” Anesthesia Station ES / 10885403477836 / 327 BD Pyxis” MedStation” ES (Main) /...Read More

Building high quality medical device software demands that we utilize many techniques to flush out latent bugs. Love this article about one technique that can be extremely helpful.Read More

Test groups beware, Google is changing their approach to loading Android applications on mobile devices as they will block sideloading of unverified Android apps. This will most likely impact 3rd party QA and software verification groups that utilize the side loading mechanism particularly during early testing phases.Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/5/2025 Class: II PRODUCT UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 Recall Number: Z-2266-2025 REASON: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 8/1/2025 Class: II PRODUCT Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software Recall Number: Z-2239-2025 REASON: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the “Stopping Power Ratio” (SPR) , RECALLING FIRM/MANUFACTURER: Philips Medical Systems (Cleveland)...Read More

Company: FUJIFILM Healthcare Americas Corporation Date of Enforcement Report: 7/30/2025 Class: II PRODUCT ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031) Recall Number: Z-2219-2025 REASON: Devices had an unapproved slabbing software function enabled for use. RECALLING FIRM/MANUFACTURER: FUJIFILM Healthcare Americas Corporation VOLUME: 293...Read More

Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Date of Enforcement Report: 7/29/2025 Class: II PRODUCT Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,...Read More

Company: Remote Diagnostic Technologies Ltd. Date of Enforcement Report: 7/25/2025 Class: II PRODUCT Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R Recall Number: Z-2175-2025 REASON: Kit USB flash drive contains outdated software, which...Read More

Company: Medtronic, Inc. Date of Enforcement Report: 7/17/2025 Class: II PRODUCT Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 7/17/2025 Class: I PRODUCT Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX Recall Number: Z-2095-2025 REASON: Certain Spectrum infusion pumps may have an incorrect version of software. RECALLING FIRM/MANUFACTURER: Baxter Healthcare Corporation VOLUME: 14 units DISTRIBUTION: US States: CA, FL, IL, KS, MI, MS, NY, OH,...Read More

It is no secret … medical device manufacturers and Health IT groups face a tremendous challenge with cybersecurity. There are high regulatory and market expectations of activities and documentation. Keeping up with the cybersecurity state of the art requires prioritization and investment. A common complaint we hear is, “navigating cybersecurity for medical devices and medical...Read More

Company: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Date of Enforcement Report: 7/8/2025 Class: II PRODUCT Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system Recall Number: Z-2097-2025 REASON: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed....Read More

Company: Change Healthcare Canada Company Date of Enforcement Report: 7/2/2025 Class: II PRODUCT Change Healthcare Cardiology Hemo Software Recall Number: Z-2071-2025 REASON: Due to complaints, software update may cause software to unexpectedly shutdown. RECALLING FIRM/MANUFACTURER: Change Healthcare Canada Company VOLUME: 29 systems DISTRIBUTION: Worldwide – US Nationwide distribution in the states of AL, AR, CA,...Read More

Company: Ortho-Clinical Diagnostics, Inc. Date of Enforcement Report: 6/27/2025 Class: II PRODUCT Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915 Recall Number: Z-2038-2025 REASON: A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even...Read More