FDA Device recall Z-2601-2016
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit
- FDA Device
- Class III
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class III recall of Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit by Siemens Healthcare Diagnostics, citing some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2601-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-07-05 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
Identifiers
| code_info | Software Version 2.2A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2601-2016%22
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