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Recall Observatory FDA recall evidence

Device product

SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system

Z-2626-2016

July 13, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 74840
Status
Terminated
Classification
Class II
Quantity
4 systems
Official record key
device-enforcement:Z-2626-2016

Official wording

Reason: 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.

Code information: Model # 8098027 Serial # 96020, 96047, 96011, and 96029

Distribution pattern: Distributed to: MI, NY, CA, KY, ND, NE

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    error between the firmware and the software