Recalls / —
—#85824
Product
RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed below including Co-Oximetry. 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.
- FDA product code
- CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K002738
- Affected lot / code info
- Software Versions prior to 3.5.1
Why it was recalled
Software: Reference sensor failure may result in inaccurate pH reuslts
Root cause (FDA determination)
Component design/selection
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics Inc
- Address
- 2 Edgewater Dr, Norwood, Massachusetts 02062-4637
Distribution
- Distribution pattern
- 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 P.R. China, Poland, Portugal, Puerto Rico, Refurb.Systems U.S.A Republic Korea, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, U.A.E., United Kingdom
Timeline
- Recall initiated
- 2009-10-30
- Posted by FDA
- 2010-03-08
- Terminated
- 2015-09-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #85824. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.