[pending] 5008X CAREsystem +CLiC +CDX;
Pending LLM rewrite. Source: FDA_DEVICE Z-0936-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- 5008X CAREsystem +CLiC +CDX;
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: M204441
- UDI-DI: 00840861102433
- All serial numbers produced with a software version prior to 4.82.4
Distribution
Distributed in 3 states:
- LA
- MA
- MN
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