From the May 2026 SoftwareCPR newsletter – an edited excerpt about cyberattacks: Last month, we explained that cybersecurity monitoring is not optional extra work. It is a basic duty across the full life of a medical device. AI can help with monitoring effectively and efficiently. That duty is becoming even more important as AI becomes...Read More

After many years of navigating the difficult task of properly validating quality system and production software tools, FDA released the “Computer Software Assurance for Production and Quality Management System Software Guidance for Industry and Food and Drug Administration Staff” on February 3, 2026. While this release may have not been noticed by many, it is...Read More

Company: Gentuity, LLC Date of Enforcement Report: 4/16/2026 Class: II PRODUCT: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; Recall Number: Z-1823-2026 REASON: The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to...Read More

Company: Philips Medical Systems Date of Enforcement Report: 4/16/2026 Class: II PRODUCT: Philips Spectral CT on Rails. Model Number: 728334 Recall Number: Z-1825-2026 REASON: Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2....Read More

Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 4/10/2026 Class: II PRODUCT: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data. Recall Number: Z-1805-2026 REASON: Potential safety issue involving the Mean Aneurysm Flow Amplitude...Read More

AI is changing cybersecurity The new cybersecurity realities: Every software download is a trust decision AI is changing cybersecurity, accelerating the threat and in new ways In our most recent newsletter, we highlighted how AI is changing cybersecurity. Recent events this past week underscore the changes and the increasing pace of change. For years, leaders...Read More

Company: Medtronic MiniMed, Inc Date of Enforcement Report: 3/24/2026 Class: II PRODUCT: MiniMed” 780G – MMT-1884 MiniMed” 780G – MMT-1886 With Software 6.60 and 6.61 Recall Number: Z-1635-2026 REASON: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61,...Read More

WARNING LETTER Exactech, Inc. dba Advita Ortho was issued a warning letter from the FDA. Excerpts from a warning letter of interest to SoftwareCPR® clients. CMS # 720250 2320 Nw 66th Ct Gainesville, FL 32653-1630 Date of inspection July 15-25, 2025 Inspection Issues: Quality System Regulation Violations This inspection revealed that these devices are adulterated...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 3/18/2026 Class: II PRODUCT Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package. Recall Number: Z-1573-2026 REASON:...Read More

Company: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Date of Enforcement Report: 2/20/2026 Class: II PRODUCT: Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR Recall Number: Z-1429-2026 REASON: Software anomaly in the patient positioning system may result in positional discrepancy. RECALLING FIRM/MANUFACTURER: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha VOLUME: 1 DISTRIBUTION: US distribution to states...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 2/27/2026 Class: II PRODUCT: cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2...Read More

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

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

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

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

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

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