Siemens Mammomat Inspiration - full-field digital recall
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Why was Siemens Mammomat Inspiration - full-field digital 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model number 10140000, serial numbers 3118, 3243 and 3309
- Product
- Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 3
- Distribution
- United States Nationwide Distribution in the states of ND, OH and SC.
- Recall date
- July 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)