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ELEKTA SOLUTIONS AB recalls Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta V
Recalled October 20, 2021 · FDA recall Z-0115-2022 · ELEKTA SOLUTIONS AB
Hazard
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. · FDA Class II
Units
2 in the U.S.
Sold at
Distribution was to ND and NC. There was no military/government distribution.
Description
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.
Product
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Manufacturer(s)
ELEKTA SOLUTIONS AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →