Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LUMINOS Lotus Max (VF11) Recalled by Siemens Medical Solutions USA, Inc Due to Under certain unlikely circumstances during a fluoroscopic examination,...
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
LUMINOS Lotus Max (VF11)
Quantity: 704 units in the United States (1945 units worldwide)
Why Was This Recalled?
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.
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