Recall Z-2601-2016— Siemens Healthcare Diagnostics Inc
Class III · Terminated
Class III FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2016-07-05, terminated 2017-08-02. It names one FDA 510(k) clearance: K113216. 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. Reason: Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States.
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-07-05
- Terminated
- 2017-08-02
- Firm location
- Norwood, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Data sourced from openFDA. This site is unofficial and independent of the FDA.