Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 2/3/2026 Class: II PRODUCT: SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS Recall Number: Z-1239-2026 REASON: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. RECALLING FIRM/MANUFACTURER: Siemens Medical Solutions USA, Inc...Read More

Company: Focalyx Technologies, LLC Date of Enforcement Report: 2/3/2026 Class: II PRODUCT: Focalyx Fusion Recall Number: Z-1243-2026 REASON: Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm...Read More

Company: Beckman Coulter, Inc Date of Enforcement Report: 2/2/2026 Class: II PRODUCT: CellMek SPS Sample Preparation System, REF: C44603, with software Recall Number: Z-1235-2026 REASON: Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid...Read More

Company: Intuitive Surgical, Inc Date of Enforcement Report: 2/2/2026 Class: II PRODUCT: Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three...Read More

Company: Medtronic MiniMed, Inc Date of Enforcement Report: 2/2/2026 Class: II PRODUCT: MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more....Read More

Company: Phillips North America Date of Enforcement Report: 01/22/2026 Class: II PRODUCT: Patient Information Center iX; Software Version Number: 4.5.0 Recall Number: Z-1156-2026 REASON: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. RECALLING FIRM/MANUFACTURER: Philips North America VOLUME: 146 units (41...Read More

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