Dialysis machines recalled over software anomalies that may stop treatment
Fresenius Medical Care is recalling 115 5008X CAREsystem units over several software anomalies with the potential to impact patient treatment, one of which may result in treatment stop.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the anomalies may impact patient treatment and can stop treatment, and no injuries are reported.
Plain-English summary
The 5008X CAREsystem +CLiC +CDX from Fresenius Medical Care Holdings, Inc. is being recalled.
The record cites 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.
The record lists 115 units, model number M204441, UDI-DI 00840861102433, covering all serial numbers produced with a software version prior to the version identified in the enforcement record. Domestic distribution covered Louisiana, Massachusetts and Minnesota. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow Fresenius Medical Care's instructions.
The recalled product
- Product
- 5008X CAREsystem +CLiC +CDX;
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Dialysis system
- Affected units
- 115
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: M204441
- UDI-DI: 00840861102433
- All serial numbers produced with a software version prior to 4.82.4
Distribution
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