FDA recall Z-0936-2026

Fresenius Medical Care Holdings, Inc. · Class II · device

Product

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.

Distribution

Domestic: LA, MA, MN;

Key facts

Status: Ongoing
Initiation date: 2025-10-25
Report date: 2025-12-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0936-2026