United StatesThe 5008X CAREsystem +CLiC +CDX (Model M204441, UDI‑DI 00840861102433, all serial numbers running software versions prior to 4.82.4) is being recalled; 115 units were distributed in LA, MA, and MN. The devices were recalled because several software anomalies could impact patient treatment, including one anomaly that can result in treatment stop if certain conditions are fulfilled.
What's being recalled
5008X CAREsystem +CLiC +CDX;
Recalling firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, United States.
How to identify it
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Domestic: LA, MA, MN;
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)