Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SYNGO Breast Care Recalled by Siemens Medical Solutions USA, Inc Due to Software issues. Siemens is voluntarily initiating a recall...
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
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
Quantity: 29 units
Why Was This Recalled?
Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).
Where Was This Sold?
This product was distributed to 12 states: CA, CO, FL, IL, MO, NE, NJ, NY, ND, OH, PA, TX
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