RapidPoint 400 Analyzers for Blood Gas, Electrolytes and… recallZ-1019-2010 · Siemens Healthcare Diagnostics Inc · initiated Oct 30, 2009
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software: Reference sensor failure may result in inaccurate pH reuslts
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-1019-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 30, 2009
- Posted by the FDA
- Mar 8, 2010
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 998 units
- Product code
- CHL
- FDA submissions
- K002738
- 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 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
Product description
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.
Code information (models, lots, serial numbers)
Software Versions prior to 3.5.1
Other devices under the same FDA submission
1 device cleared under K002738 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RAPIDPoint® 400/405/500 Wash/Waste Cartridge 10329097Siemens Healthcare Diagnostics Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 53541).
- Z-1020-2010 · TerminatedRapidPoint 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 car…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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