Home / Recalls / ELEKTA SOLUTIONS AB / Z-0115-2022

Z-0115-2022 Class II Terminated

Recalled by ELEKTA SOLUTIONS AB — Stockholm, N/A

Recall Details

Product Type: Devices
Report Date: October 20, 2021
Initiation Date: September 28, 2021
Termination Date: June 14, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 in the U.S.

Product Description

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 Pattern

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

Code Information

Elekta Harmony Pro, Serial #441009, UDI (01) 05060191071604; Elekta Infinity, Serial #156645, UDI (01) 05060191071543; and Elekta Versa HD, Serial #156646, #156477, and #156648, UDI (01) 05060191071574