PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 17, 2017 Initiated: April 10, 2017 #Z-2040-2017

Product Description

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

Reason for Recall

Potential Patient Demographic Error with Blank Patient ID Field

Details

Units Affected
159 units
Distribution
Nationwide Foreign: Australia Bangladesh Chile Colombia France Germany Hong Kong India Ireland Japan Latvia Mexico Spain Switzerland Thailand Uruguay
Location
Norwood, MA

Frequently Asked Questions

What product 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. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 159 units.
Why was this product recalled?
Potential Patient Demographic Error with Blank Patient ID Field
Which agency issued this recall?
This recall was issued by the FDA Devices on May 17, 2017. Severity: Moderate. Recall number: Z-2040-2017.