Recall Z-1297-2019 ยท IYE Accelerator, Linear, Medical
Elekta Limited
Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Info
| Date | May 8, 2019 (initiated Apr 3, 2019) |
| Status | Terminated |
| Reason | There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated. |
| Root cause | Labeling design |
| Action | Elekta notified customers on about 04/03/2019 via email with "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Instructions included to ensure all staff working with Elekta Unity are aware of the issue and recall information and post the recall notice in a place accessible to all users, e.g. Instructions for use, until the recall is closed. Additionally customer were asked to complete and return the Acknowledgement Form. |
| Quantity | 9 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182076 | Elekta Unity Elekta Limited, Dec 4, 2018 |