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Siemens Medical Solutions USA, Inc recalls Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Recalled July 17, 2013 · FDA recall Z-1694-2013 · Siemens Medical Solutions USA
Hazard
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 Class II
Units
3
Sold at
United States Nationwide Distribution in the states of ND, OH and SC.
Description
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
Product
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →