Z-2214-2024Class II

Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint...

Name: Z-2214-2024 Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2024-05-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-05-17 / Open, Classified / root cause: software

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint... on 2024-05-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2214-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-17
Posted: 2024-06-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
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 ;
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: software
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2214-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2214-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-26

Product code CHL

K192240Class IIRAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. / cleared 2020-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)