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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MUE
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