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.
FDA Recall Z-1019-2010 · Posted 2010-03-08
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Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2009-10-30
Date Terminated2015-09-04
Product Quantity998 units
Reason for Recall
Software: Reference sensor failure may result in inaccurate pH reuslts
Firm 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.
Root Cause
Component design/selection
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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