FDA-Device2017-05-17Class II

RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306

Siemens Healthcare Diagnostics Inc
Hazard

Potential Patient Demographic Error with Blank Patient ID Field

Sold states
Nationwide Foreign: Australia Bangladesh Chile Colombia France Germany Hong Kong India Ireland Japan Latvia Mexico Spain Switzerland Thailand Uruguay
Affected count
159 units
Manufactured in
2 Edgewater Dr, N/A, Norwood, MA, United States
Products
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2040-2017

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