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

This recall has been terminated (originally issued September 28, 2021).

Company: Elekta Solutions Ab
Recall Initiated: September 28, 2021
Terminated: June 14, 2024
Recall Number: Z-0115-2022
Quantity: 2 in the U.S.
Firm Location: Stockholm Sweden
Official Source: View on FDA website ↗

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.

NC ND

Lot / Code Info

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

Root Cause

Nonconforming Material/Component

Action Taken

The recalling firm issued an Urgent Important Field Safety Notification dated September 2021 via email on 9/28/2021. The Subject of the letter was addressed for the service user regarding precautions to be taken when handling diode D1. The notification described the details of the failure and that Elekta is currently working on a solution to eliminate this failure mode. The notice was to be placed in an area accessible to all users until the correction is made. Appropriate personnel who work with this product are to be advised on the content of the letter. Corrective actions were provided regarding removing the modulator covers and the Personal Protective Equipment that must be worn by the engineer, including a safety visor, protective jacket, and gloves. Instructions for removing the RDO diode (D1) were provided. An Acknowledgment Form was included for completion and return to Elekta no later than 30 days for acknowledgement that the service user has read and understands the notification and accepts the implementation of any given recommendation.