FDA Device recall Z-0936-2026
5008X CAREsystem +CLiC +CDX
- FDA Device
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of 5008X CAREsystem +CLiC +CDX by Fresenius Medical Care Holdings, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0936-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-25 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | LA, MA, MN |
Product
5008X CAREsystem +CLiC +CDX;
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.
Identifiers
| code_info | Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-05-13 · Fresenius Medical Care Holdings
All Fresenius Medical Care Holdings recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0936-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.