Siemens Healthcare Diagnostics Inc recalls RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment…

Recall date

April 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2040-2017

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics Inc

Sold / distributed

Nationwide Foreign: Australia Bangladesh Chile Colombia France Germany Hong Kong India Ireland Japan Latvia Mexico Spain Switzerland Thailand Uruguay

Why it was recalled

Potential Patient Demographic Error with Blank Patient ID Field

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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