FDA-Device2021-10-20Class II
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
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.
Sold states
Distribution was to ND and NC. There was no military/government distribution.
Affected count
2 in the U.S.
Manufactured in
Box 7593, KUNGSTENSGATAN 18, Stockholm, N/A, Sweden
Products
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0115-2022Don't want to check this manually?
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