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Recall Observatory FDA recall evidence

Device product

The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.

Z-1962-2015

May 06, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 71073
Status
Terminated
Classification
Class II
Quantity
2713 devices
Official record key
device-enforcement:Z-1962-2015

Official wording

Reason: D50 and D51 diagnostic error codes are not functional.

Code information: Siemens Material Number (SMN): 10321852, 10470366, 10491395, 10335524

Distribution pattern: Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany,Georgia, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Venezuela and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    D50 and D51 diagnostic error codes are not functional.