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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 July 11, 2013
Recall Status1 Terminated on February 21, 2014
Recall Number Z-1694-2013
Recall Event ID 65487
Premarket Notification
510(K) Number
K122286 
Product Classification Full Field Digital,System,X-Ray,Mammographic - Product Code MUE
Product Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Code Information Model number 10140000, serial numbers 3118, 3243 and 3309
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
Manufacturer Reason
for Recall
Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this iss
FDA Determined
Cause 2
DESIGN: Device Design
Action Siemens issued an Update Instructions XP031/12/S by letter to the affected customers. For affected sites, a Siemens Service Engineer will inspect the unit and make any adjustments needed. Following the inspection and adjustments, a proper calibration will be completed. For questions call 610-448-3237 and 610-446-4634.
Quantity in Commerce 3
Distribution United States Nationwide Distribution in the states of ND, OH and SC.
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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