FDA Medical devices recall ·
5008X CAREsystem +CLiC +CDX recall
- Recall number
- Z-0936-2026
- Date
- (initiated October 25, 2025)
- Company / brand
- Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920, Waltham, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 115 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
5008X CAREsystem +CLiC +CDX;
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
Distribution
Domestic: LA, MA, MN;
States: Louisiana Massachusetts Minnesota
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0936-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.