Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 1/14/2026 Class: II PRODUCT: Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227....Read More

Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 1/14/2026 Class: II PRODUCT: Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5....Read More

An excellent tool in your arsenal for ensuring software quality is to establish software design patterns. Software design patterns can help reduce the insertion of software defects and also facilitates finding software defects during development. One to consider is GRASP software design guidelines that help to create consistency with software class responsibility. GRASP is acronym...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 1/8/2026 Class: II PRODUCT: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 Recall Number: Z-0999-2026 REASON: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without...Read More

Company: CareFusion 303, Inc Date of Enforcement Report: 1/8/2026 Class: II PRODUCT: BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02,...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 1/8/2026 Class: II PRODUCT: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 Recall Number: Z-0999-2026 REASON: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 1/8/2026 Class: II PRODUCT: BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02,...Read More

Struggling with cybersecurity planning, execution, and postmarket surveillance? Asking yourself, “what does FDA expect?  If it is any consolation, most medical device manufacturers are right there with you! But we have noticed that many struggles likely could have been avoided. The good news is that cybersecurity is on your radar – likely that is why...Read More

… declares the table of contents for an article, subtitled Software problems are responsible for 20 recalls a month in IEEE’s Spectrum magazine December 2025 issue (the article is available without an IEEE account: https://spectrum.ieee.org/medical-device-recalls) The article includes several summary charts about U.S. Food and Drug Administration (FDA) medical device recall data back to 2005,...Read More

Why Software Keeps Failing is the title of the editor’s page for IEEE’s Spectrum December 2025 issue. The answer to “why software keeps failing”? Lessons are learned but not applied. From the editor: In 2005’s “Why Software Fails,” in IEEE Spectrum, a seminal article documenting the causes behind large-scale software failures, Charette noted, “The biggest...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report: 12/23/2025 Class: II PRODUCT Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL...Read More

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: Howmedica Osteonics Corp. Date of Enforcement Report: 12/19/2025 Class: II PRODUCT The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED...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