Recall Z-2040-2017 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
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
| Date | Apr 10, 2017 |
| Status | Terminated |
| Reason | Potential Patient Demographic Error with Blank Patient ID Field |
| Root cause | Software design |
| Action | Siemens Healthcare issued an An Urgent Field Safety Notice via e-mail to all affected Siemens Healthcare Diagnostics Regional offices on April 10, 2017 both in the United States and outside of the United States. This notice informs customers of the issue, risk to health and actions to be taken by the customer. A Field Correction Effectiveness Check form to be completed and returned. Questions: Contact your Siemens Customer Care Center or your local Siemens technical support representative |
| Quantity | 159 units |
| Distribution | Nationwide Foreign: Australia Bangladesh Chile Colombia France Germany Hong Kong India Ireland Japan Latvia Mexico Spain Switzerland Thailand Uruguay |
| FDA record | Open on fda.gov |