RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software Versions prior to 3.5.1. The Siemens 400 s
FDA device recall Z-1019-2010 · posted 2010-03-08 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Reason for recall
- Software: Reference sensor failure may result in inaccurate pH reuslts
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 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
- Date initiated
- 2009-10-30
- Date posted
- 2010-03-08
- Date terminated
- 2015-09-04
- Location
- Norwood, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAYER RAPIDPOINT 400 SYSTEM (K002738) | Bayer Corp. | 2000-12-19 |