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Siemens Medical Solutions USA, Inc recalls Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams,
Recalled October 29, 2014 · FDA recall Z-0086-2015 · Siemens Medical Solutions USA
Hazard
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 · FDA Class II
Units
3
Sold at
US Distribution in states of: NY, VA, and MA.
Description
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
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →