Fresenius 5008X CAREsystem dialysis machine recalled for software anomalies affecting treatment
Fresenius Medical Care identified several software problems in the 5008X CAREsystem +CLiC +CDX dialysis machine that could interfere with patient treatment. One anomaly could potentially cause the machine to stop treatment if certain conditions occur. This affects 115 units with software versions older than 4.82.4.
From the FDA notice · Read the official notice ↗ · All Fresenius Medical Care recalls
What to do
- Check if your machine is model M204441 with serial numbers produced before software version 4.82.4
- Do not use the affected machine until you receive instructions from Fresenius Medical Care
- Contact Fresenius Medical Care immediately for a software update or replacement
- Notify your dialysis center or healthcare provider if you have this device
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 5008X CAREsystem +CLiC +CDX;
- Sold in
- Domestic: LA, MA, MN;
- Made for
- All ages (under 100 years)
Details
- Units affected
- 115 units
- Illnesses reported
- None reported
- Manufactured in
- 920 Winter St Bld 920, Waltham, MA, United States
- Classification
- Class II
- Recall number
- Z-0936-2026
In the FDA's words
- Description
- 5008X CAREsystem +CLiC +CDX; 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. Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4; Distribution: Domestic: LA, MA, MN; Affected quantity: 115 units
- 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.