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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens MAMMOMAT Inspiration

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  Class 2 Device Recall Siemens MAMMOMAT Inspiration see related information
Date Initiated by Firm April 25, 2014
Date Posted May 20, 2014
Recall Status1 Terminated 3 on December 15, 2014
Recall Number Z-1638-2014
Recall Event ID 68224
510(K)Number K122286  
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
Product MAMMOMAT Inspiration.

Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Code Information (Material number 10549894) with serial numbers 5000 through 5029.
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		 There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
FDA Determined
Cause 2		 Device Design
Action A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.
Quantity in Commerce 5
Distribution Distributed in the states of GA, FL, NY, NV, 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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