Official recall record
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (C
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-05-17
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00630414286143
- Brand on record
- Siemens Healthcare Diagnostics Inc
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-07-07 · US FDA — Medical Devices
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. - 2025-06-26 · US FDA — Medical Devices
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. - 2024-09-24 · US FDA — Medical Devices
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515