Recall Z-1694-2013
Siemens Medical Solutions USA, Inc · initiated February 28, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Codes / lots: Model number 10140000, serial numbers 3118, 3243 and 3309
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: Device Design
Action taken
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.
Details
- Recall number
- Z-1694-2013
- Initiated
- February 28, 2013
- Posted by FDA
- July 11, 2013
- Terminated
- February 21, 2014
- Product code
- MUE – Full Field Digital, System, X-Ray, Mammographic
- Quantity
- 3
- Distribution
- United States Nationwide Distribution in the states of ND, OH and SC.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA