FDA-Device2013-07-17Class II

Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

Siemens Medical Solutions USA, Inc
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

Sold states
United States Nationwide Distribution in the states of ND, OH and SC.
Affected count
3
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2013

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