Siemens Healthcare Diagnostics Inc: Device Recall
Recall #Z-2214-2024 · 05/17/2024
Recall Details
- Recall Number
- Z-2214-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Status
- Ongoing
- Date Initiated
- 05/17/2024
- Location
- Norwood, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units US
Reason for Recall
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.
Product Description
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 ;
Distribution Pattern
Worldwide - US Nationwide distribution in the states of FL, GA, LA, MI, NC and the countries of Chile, Costa Rica, France, Germany, Japan, Lebanon, Mexico, Netherlands, New Zealand, Poland, Spain, Turkey, United Kingdom.
Other Recalls by Siemens Healthcare Diagnostics Inc
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 09/22/2025
- Class II: Risk 08/11/2025