RAPIDPoint 500 Blood Gas Analyzer — Class II medical device recall Z-2479-2015

Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2015-09-09, distributed nationwide. When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could pot

Recall number	`Z-2479-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Healthcare Diagnostics Inc, Norwood, MA, United States
Recall initiated	2015-07-28
Classified	2015-08-28
Reported by FDA	2015-09-09
Terminated	2017-02-17
Distributed	Nationwide (US)
Countries outside the US	AE, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IN, IT, JP, KE, KR, KW, LB, LT, LU, LV, MX, MY, NL, NO, NZ, PE, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TN, TR, TW, VN, ZA
Quantity	5,241 units

Product

RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.

Reason for recall

When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2479-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.