Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography Recalled by Siemens Medical Solutions USA, Inc Due to Firm became aware of an unintended behavior when...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Medical Solutions USA, Inc directly.
Affected Products
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Quantity: 3
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc has 613 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report