Device product
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Z-2601-2016
Product summary
- Event
- Event 74564
- Status
- Terminated
- Classification
- Class III
- Quantity
- 76
- Official record key
device-enforcement:Z-2601-2016
Official wording
Reason: Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Code information: Software Version 2.2A
Distribution pattern: Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Derived failure modes
-
Unknown
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States