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Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is
Recalled August 31, 2016 · FDA recall Z-2601-2016 · Siemens Healthcare Diagnostics
Hazard
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States · FDA Class III
Units
76
Sold at
Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Description
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
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
Manufacturer(s)
Siemens Healthcare Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →