Recall Z-2214-2024 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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 ;
| Date | Jun 26, 2024 (initiated May 17, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Software Design Change |
| Action | 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 ca |
| Quantity | 9 units US |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192240 | RAPIDPoint 500e Blood Gas System Siemens Healthcare Diagnostics, Inc., Mar 27, 2020 |