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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 Recall
Siemens MAMMOMAT Inspiration
see related information
Date Posted May 20, 2014
Recall Status1 Open
Recall Number Z-1638-2014
Recall Event ID 68224
Premarket Notification
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, Pennsylvania 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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