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.
Recall
- Recall Number
- Z-0086-2015
- Event Number
- 69371
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- MUE
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 18, 2014
- Posted
- October 17, 2014
- Terminated
- February 24, 2015
- Address
- 51 Valley Stream Pkwy, Malvern, PA, 19355
Description
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.
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
A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken.
US Distribution in states of: NY, VA, and MA.
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