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: 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

Company: Philips North America Llc Date of Enforcement Report: 6/26/2025 Class: II PRODUCT Spectral CT. Computed tomography X-ray system. Recall Number: Z-2034-2025 REASON: Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report: 6/25/2025 Class: II PRODUCT REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&)....Read More

Company: Insulet Corporation Date of Enforcement Report: 6/24/2025 Class: II PRODUCT Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 6/24/2025 Class: II PRODUCT Product Name [REF]: Supply Server CCE Enterprise SW Site License (2-5) BD Pyxis Logistics [806] 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) 10885403512667 [323]...Read More

Company: Bigfoot Biomedical Date of Enforcement Report: 6/20/2025 Class: II PRODUCT Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin...Read More

Company: ICU Medical, Inc. Date of Enforcement Report: 6/18/2025 Class: II PRODUCT ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump Recall Number: Z-1990-2025 REASON: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit...Read More

Company: Philips Medical Systems Nederland B.V. Date of Enforcement Report: 6/12/2025 Class: II PRODUCT Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282;...Read More

Company: Turncare, Inc Date of Enforcement Report: 6/12/2025 Class: II PRODUCT Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix) Recall Number: Z-1967-2025 REASON: A software issue where “low” and “terminal” battery alerts did not display on the screen to the user in specific circumstances when...Read More

Company: Mobius Mobility LLC Date of Enforcement Report: 6/12/2025 Class: II PRODUCT iBOT PMD with software version 01.05.24. Personal Mobility Device. Recall Number: Z-1965-2025 REASON: Software issue that could potentially lead to the device tipping over from Balance Mode. RECALLING FIRM/MANUFACTURER: Mobius Mobility LLC VOLUME: 442 units DISTRIBUTION: US Nationwide distribution in the states of...Read More

Company: QUANTUM SURGICAL SAS Date of Enforcement Report: 6/9/2025 Class: II PRODUCT EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous...Read More

Company: Cardinal Health 200, LLC Date of Enforcement Report: 6/6/2025 Class: II PRODUCT SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Recall Number: Z-1917-2025 REASON: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or...Read More

Company: Zyno Medical LLC Date of Enforcement Report: 6/6/2025 Class: I PRODUCT Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Recall Number: Z-1865-2025 REASON: Unreleased software versions were installed on distributed devices without verification or validation. RECALLING FIRM/MANUFACTURER: Zyno Medical LLC VOLUME: 613 units DISTRIBUTION:...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 6/5/2025 Class: II PRODUCT DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 Recall Number: Z-1913-2025 REASON: A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being...Read More

Company: Virtual Incision Corporation Date of Enforcement Report: 6/4/2025 Class: II PRODUCT MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3 Recall Number: Z-1905-2025 REASON: The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display...Read More

Design Approval Requirements and Signatures: Navigating 21 CFR 820 and ISO 13485 Medical device manufacturers often struggle with a fundamental question: What signature requirements apply to design input and design output approvals? Understanding how 21 CFR 820 Design Controls and ISO 13485 address design approvals is essential for achieving both compliance and operational efficiency. This...Read More

German court parks four Volkswagen execs in jail over Dieselgate scandal in which software used to test its vehicles’ pollution emissions was intentionally modified to falsify results.Read More

Company: Copan WASP Date of Enforcement Report: 5/21/2025 Class: II PRODUCT PhenoMATRIX Recall Number: Z-1812-2025 REASON: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and...Read More

Company: Copan WASP Date of Enforcement Report: 05/21/2025 Class II PRODUCT PhenoMATRIX Recall Number: Z-1812-2025 REASON: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and...Read More

Company: Echopixel, Inc. Date of Enforcement Report: 5/21/2025 Class II PRODUCT TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer...Read More

Company: Echopixel, Inc. Date of Enforcement Report: 5/16/2025 Class II PRODUCT True 3D Viewer, Model: EP-00003 Recall Number: Z-1785-2025 REASON: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image...Read More

Company: Echopixel, Inc. Date of Enforcement Report: 5/16/2025 Class II PRODUCT True 3D Viewer, Model: EP-00003 Recall Number: Z-1785-2025 REASON: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report: 5/15/2025 Class II PRODUCT DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC)...Read More