Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Reported: July 17, 2013 Initiated: February 28, 2013 #Z-1694-2013
Product Description
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 3
- Distribution
- United States Nationwide Distribution in the states of ND, OH and SC.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 3.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2013. Severity: Moderate. Recall number: Z-1694-2013.
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