Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro Recalled by ELEKTA SOLUTIONS AB Due to There is a risk that the Diode D1...
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 ELEKTA SOLUTIONS AB directly.
Affected Products
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Quantity: 2 in the U.S.
Why Was This Recalled?
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Where Was This Sold?
This product was distributed to 2 states: NC, ND
About ELEKTA SOLUTIONS AB
ELEKTA SOLUTIONS AB has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report