FDAFDA · Food and drugs·Recall number Z-1694-2013
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Published July 17, 2013 · Recall initiated: February 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- United States Nationwide Distribution in the states of ND, OH and SC.
- Lot
- Model number 10140000, serial numbers 3118, 3243 and 3309
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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