Fresenius Medical Care Holdings, Inc. is recalling 115 units of the 5008X CAREsystem +CLiC +CDX dialysis machine (Model M204441). The recall was initiated because of several software anomalies that can impact patient treatment, including one specific error that could cause the machine to stop operating entirely under certain conditions. Consumers should stop using affected units and contact the manufacturer or their distributor to arrange for a software update or correction.
A software malfunction may cause the dialysis machine to unexpectedly stop during use, which could result in an interruption of necessary medical treatment for the patient.
All serial numbers produced with a software version prior to 4.82.4 are affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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