5008X CAREsystem +CLiC +CDX;
Reported: December 24, 2025 Initiated: October 25, 2025 #Z-0936-2026
Product Description
5008X CAREsystem +CLiC +CDX;
Reason for Recall
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.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 115 units
- Distribution
- Domestic: LA, MA, MN;
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
5008X CAREsystem +CLiC +CDX;. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 115 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Moderate. Recall number: Z-0936-2026.
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