FDA recall Z-0115-2022

Product

Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.

Reason for recall

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.

Distribution

Distribution was to ND and NC. There was no military/government distribution.

Key facts

Status

Terminated

Initiation date

2021-09-28

Report date

2021-10-20

Termination date

2024-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0115-2022