—#208053

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 ;

FDA product code: CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K192240
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Software Design Change

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc
Address: 2 Edgewater Dr, Norwood, Massachusetts 02062-4637

Distribution

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.

Timeline

Recall initiated: 2024-05-17
Posted by FDA: 2024-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208053. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.