5008X CAREsystem +CLiC +CDX recall: Software Issue
5008X CAREsystem +CLiC +CDX;
Why was 5008X CAREsystem +CLiC +CDX 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
- Product
- 5008X CAREsystem +CLiC +CDX;
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 115 units
- Distribution
- Domestic: LA, MA, MN;
- Recall date
- December 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)