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Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
Recalled August 31, 2016 · FDA recall Z-2625-2016 · Siemens Medical Solutions USA
Hazard
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector. · FDA Class II
Units
2 systems
Sold at
Distributed to: MI, NY, CA, KY, ND, NE
Description
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
Product
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →