Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SOMATOM Definition Edge Recalled by Siemens Medical Solutions USA, Inc Due to software bug issues for SW-Version VA48A_SP0. The following...
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
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Quantity: 113 total
Why Was This Recalled?
software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
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