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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 February 28, 2013
Date Posted July 11, 2013
Recall Status1 Terminated 3 on February 21, 2014
Recall Number Z-1694-2013
Recall Event ID 65487
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 PA 19355
For Additional Information Contact
610-219-6300
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		 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 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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