Recall Z-2473-2020 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Unity, Image-Guided Radiation Therapy System
| Date | Dec 18, 2019 |
| Status | Terminated |
| Reason | There have been reports of excessive heating in the MRL Gradient Connection Module. |
| Root cause | Process control |
| Action | Initially, the firm issued an email on 12/18/2019 to their field engineers which said they had attached a "Knowledge Article" which provided instructions on how to inspect the Philips Marlin 1.5T system used in the Elekta Unity MR Linac. On 5/11/2020, the firm issued an Urgent Important Field Safety Notification dated May, 2020, via email to consignees which explained the problem, clinical impact, and said that initial corrective actions have been performed on all impacted sites to ensure the gradient coil connection assembly is correct. It goes onto say that extensive testing of the incorre |
| Quantity | 21 devices |
| Distribution | Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192482 | Elekta Unity Elekta Limited, Dec 5, 2019 |