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Recall Observatory FDA recall evidence

Device product

Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.

Z-0948-2013

November 27, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 64376
Status
Terminated
Classification
Class II
Quantity
896
Official record key
device-enforcement:Z-0948-2013

Official wording

Reason: Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

Code information: Model numbers - 7740769, 8098027, 10430603, and 10590000.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.