PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 29, 2014 Initiated: September 18, 2014 #Z-0086-2015

Product 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.

Reason for Recall

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

Details

Units Affected
3
Distribution
US Distribution in states of: NY, VA, and MA.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 3.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2014. Severity: Moderate. Recall number: Z-0086-2015.

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