device recall
saveFresenius Medical Care Holdings, Inc. device recall (Cls II)
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5008X CAREsystem +CLiC +CDX; — Reason: 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. — Status: Ongoing
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same company · ±60 days · 6
- device 510kFresenius Medical Care Renal Therapies Group, LLC — DIASAFEplusUS (F00013010) (510k cleared)Oct 9, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — AquaC UNO H (510k cleared)Nov 14, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — BCM2-Body Composition Monitor (510k cleared)Nov 24, 2025
- device 510kFresenius Medical Care North America — AquaA (510k cleared)Sep 9, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) (510k cleared)Sep 9, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — FX CorAL 40; FX CorAL 50 (510k cleared)Dec 18, 2025
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- tag510(k) Clearance14 co-mentions · 14 sources
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- tagGastroenterology13 co-mentions · 13 sources
- tagNephrology13 co-mentions · 13 sources
- tagUrology13 co-mentions · 13 sources
- tagRecall8 co-mentions · 6 sources
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