FDA-Device2016-08-31Class II
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Siemens Medical Solutions USA, Inc
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.
Sold states
Distributed to: MI, NY, CA, KY, ND, NE
Affected count
4 systems
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2626-2016Don't want to check this manually?
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