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Recall Observatory FDA recall evidence

Device product

Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.

Z-0086-2015

September 18, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 69371
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0086-2015

Official wording

Reason: The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i

Code information: material #10140000, with serial numbers: 5018 3849 5042

Distribution pattern: US Distribution in states of: NY, VA, and MA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i