February 6, 2025

Feb

FDA Recall: Software Error Caused an Increase in Tray Gripper Motion Erros Leading to Intermittent Hard Stops

February 6, 2025Allison PateNews

Company: Beckman Coulter, Inc. Date of Enforcement Report: 2/06/2025 Class II PRODUCT Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument Recall Number: Z-1115-2025 REASON: A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results. RECALLING FIRM/MANUFACTURER: Beckman Coulter,...

Feb

FDA Recall: Surgical Parameters May Have Erros Resulting in Incorrect Calculations

February 6, 2025Allison PateNews

Company: Medicrea International. Date of Enforcement Report: 2/06/2025 Class II PRODUCT UNiD” Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display,...

Feb

FDA Recall: Software Anomalies Leading to Surgical Parameters Errors Resulting in Incorrect Calculations

February 6, 2025Allison PateNews

Company: Medicrea International Date of Enforcement Report: 2/06/2025 Class II PRODUCT UNiD” Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display,...

FDA Recall: Software Error Caused an Increase in Tray Gripper Motion Erros Leading to Intermittent Hard Stops

FDA Recall: Surgical Parameters May Have Erros Resulting in Incorrect Calculations

FDA Recall: Software Anomalies Leading to Surgical Parameters Errors Resulting in Incorrect Calculations

Upcoming Public Courses

Corporate Office

Day

FDA Recall: Software Error Caused an Increase in Tray Gripper Motion Erros Leading to Intermittent Hard Stops

FDA Recall: Surgical Parameters May Have Erros Resulting in Incorrect Calculations

FDA Recall: Software Anomalies Leading to Surgical Parameters Errors Resulting in Incorrect Calculations

Upcoming Public Courses

Corporate Office