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Recall Observatory FDA recall evidence

Device product

MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.

Z-1638-2014

April 25, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 68224
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-1638-2014

Official wording

Reason: There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.

Code information: (Material number 10549894) with serial numbers 5000 through 5029.

Distribution pattern: Distributed in the states of GA, FL, NY, NV, and MA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.