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
This recall has been terminated (originally issued August 19, 2016).
- Recall Initiated
- July 5, 2016
- Posted
- August 19, 2016
- Terminated
- August 2, 2017
- Recall Number
- Z-2601-2016
- Quantity
- 76
- Firm Location
- Norwood, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Distribution
Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Lot / Code Info
Software Version 2.2A
Root Cause
Under Investigation by firm
Action Taken
Siemens sent a Customer Notification dated July 2016 to all affected domestic (US) customers via Federal Express on July 5, 2016. Customers were asked to take the following actions: Please do not use the dialysate mode. If you have enabled this feature, please disable it by following these instructions: 1. At the System screen, select Setup. 2. Select Secured Options > Analysis Options. 3. Unselect Dialysate. 4. Select the Continue button 3 times. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check attached to this letter within 7 days. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens Technical Support representative. For questions regarding this recall call 781-269-3000.