Recall Z-1675-2023 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
| Date | Jun 2, 2023 (initiated Apr 6, 2023) |
| Status | Open, Classified |
| Reason | There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems. |
| Root cause | Process design |
| Action | The recalling firm issued the Field Safety Notice dated March 2023 via email on 4/6/2023 describing the problem, the clinical impact, and the recommended user action, which is that no actions are required to be taken by the user. The Unity system is safe for clinical use without restriction. The consignee is informed the letter is to notify them there will be action taken on the Elekta Unity system to further reduce the potential risk of overheating within the MR Gradient Coil which could lead to system downtime. The letter is to be posted in a place accessible to all users and appropriate |
| Quantity | 18 devices |
| Distribution | US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212114 | Elekta Unity Elekta Solutions AB, Oct 1, 2021 |