FDA Device recall Z-2214-2024
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China)…
- FDA Device
- Class II
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China)… by Siemens Healthcare Diagnostics, citing siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2214-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-17 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
Reason
Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.
Identifiers
| code_info | UDI-DI: (1)RAPIDPoint 500e Blood Gas System (USA) 00630414286143; (2)RAPIDPoint 500e Blood Gas System (China) 0063…UDI-DI: (1)RAPIDPoint 500e Blood Gas System (USA) 00630414286143; (2)RAPIDPoint 500e Blood Gas System (China) 00630414286150; (3) RAPIDPoint 500e Blood Gas System (Japan) 00630414286167; (4) RAPIDPoint 500e Blood Gas System (ROW) 00630414286174 Software Version 5.3. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2214-2024%22
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