Device product
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Z-1694-2013
Product summary
- Event
- Event 65487
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-1694-2013
Official wording
Reason: 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
Code information: Model number 10140000, serial numbers 3118, 3243 and 3309
Distribution pattern: United States Nationwide Distribution in the states of ND, OH and SC.
Derived failure modes
-
Unknown
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