Day

December 17, 2025
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....
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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