Recall Z-0115-2022 ยท IYE Accelerator, Linear, Medical
ELEKTA SOLUTIONS AB
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
| Date | Sep 28, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 2 in the U.S. |
| Distribution | Distribution was to ND and NC. There was no military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Elekta Limited, Jun 11, 2021 |