FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc: 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
- Recall number
- Z-2601-2016
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- 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
- Status
- Terminated
- Initiated
- 2016-07-05
- Posted
- 2016-08-19
- Terminated
- 2017-08-02
- Reason
- Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 76
- Distribution
- Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
- Lot, serial or model codes
- Software Version 2.2A
- 510(k) numbers
- ["K113216"]
- PMA numbers
- not on file
- Product code
- KHP
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28