Siemens Healthcare Diagnostics Inc 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 ; Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

Siemens Healthineers issued Urgent Medical Device Correction Letter (POC 24-015.A.US) on 5/1/7/24 to US customers via Fed'x. An Urgent Field Safety Notice (UFSN) POC 24-015.A.OUS was issued to all OUS Siemens reporting sites with affected customers for distribution and regional reporting to their local competent authorities. Letter states reason for recall, health risk and action to take: " Please review this letter with your Medical Director to determine the appropriate course of action. " Siemens will convert all RAPIDPoint 500e systems at software v5.3 to v5.2 regardless of whether the capillary sample mode is used. The software conversion will be performed by Siemens Service group. Please contact Siemens customer support for the system software conversion. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " Adverse reactions or quality problems experienced with the use of the affected products listed in the above table may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " For any questions, you may call our 24/7 Customer Service USA line at 877-229-3711.