Z-2214-2024 Class II Ongoing
FDA device recall Z-2214-2024 was initiated by Siemens Healthcare Diagnostics Inc on May 17, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 9 units US.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 3, 2024
- Initiation Date
- May 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units US
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 ;
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.
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2214-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026