Recall Z-1019-2010 · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software Versions prior to 3.5.1. The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.
| Date | Mar 8, 2010 (initiated Oct 30, 2009) |
| Status | Terminated |
| Reason | Software: Reference sensor failure may result in inaccurate pH reuslts |
| Root cause | Component design/selection |
| Action | An "Urgent Field Safety Notice" dated September 2009 was sent via overnight mail to customers and included software Version 3.5.2 with instructions for install that will detect and prevent the reporting of potentially errant test results. The customers are requested to please install the included software update immediately and return the attached Fax back form. Siemens will provide the mandatory update to all customers with the Rapidpoint 400 /405 test system. If you have any questions, please contact your local Technical Support at 508-359-3877. |
| Quantity | 998 units |
| Distribution | Worldwide distribution: USA and Australia, Austria, Bahamas, Barbados, Belgium, Bosnia Herzeg, Brazil, Canada, Canary Islands, Chile, Croatia, Czech Republic, Egypt, France, Germany, Holy See (Vatican City State) Hong Kong, Ireland, Italy, Japan, Macedonia, Malaysia, M¿xico, New Zealand Not assigned |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002738 | BAYER RAPIDPOINT 400 SYSTEM Bayer Corp., Dec 19, 2000 |