Device product
The Rapidlab 1260 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-1961-2015
Product summary
- Event
- Event 71073
- Status
- Terminated
- Classification
- Class II
- Quantity
- 122 devices
- Official record key
device-enforcement:Z-1961-2015
Official wording
Reason: D50 and D51 Diagnostic error codes are not functional.
Code information: Siemens Material Number (SMN): 10321846, 10491394, 10339910
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
D50 and D51 Diagnostic error codes are not functional.