Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
FDA Recall Z-0115-2022 · Posted None
Recalling FirmELEKTA SOLUTIONS AB
Recall StatusTerminated
Product CodeIYE
Date Initiated2021-09-28
Date Terminated2024-06-14
Product Quantity2 in the U.S.
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.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution was to ND and NC. There was no military/government distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.