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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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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

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