ELEKTA SOLUTIONS AB: Medical Device Recall in 2021 - (Recall #: Z-0115-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 28, 2021

Date Posted: October 20, 2021

Recall Number: Z-0115-2022

Event ID: 88771

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.

Status: Terminated

Product Quantity: 2 in the U.S.

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated