Recall Z-0706-2019 ยท IYE Accelerator, Linear, Medical
Elekta Limited
Elekta Unity
| Date | Jan 4, 2019 |
| Status | Completed |
| Reason | In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore. |
| Root cause | Under Investigation by firm |
| Action | The firm notified their consignees about the issue on 01/04/2019 and will install additional fixation. |
| Quantity | 2 units |
| Distribution | TX and WI, Germany, Denmark, Netherlands, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182076 | Elekta Unity Elekta Limited, Dec 4, 2018 |