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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Mammomat Inspiration mammography systems

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  Class 2 Device Recall Siemens Mammomat Inspiration mammography systems see related information
Date Initiated by Firm September 18, 2014
Date Posted October 17, 2014
Recall Status1 Terminated 3 on February 24, 2015
Recall Number Z-0086-2015
Recall Event ID 69371
510(K)Number k122286  
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
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.
Code Information material #10140000, with serial numbers: 5018 3849 5042  
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer 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
FDA Determined
Cause 2		 Process control
Action A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken.
Quantity in Commerce 3
Distribution US Distribution in states of: NY, VA, and MA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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