Recall Z-1980-2019 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Unity, Image-Guided Radiation Therapy System 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.
| Date | Jul 16, 2019 (initiated Jun 24, 2019) |
| Status | Terminated |
| Reason | The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA. |
| Root cause | Software design |
| Action | The firm, Elekta, disseminated their "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" by email on 06/24/2019 to its customers. The notices identified the problem, provided recommended actions, and requested the notice be placed in a place accessible to all users. Customers were also instructed to complete and return the Acknowledgement Form. A software update will be provided once available. If you have any questions, contact the Post Market Surveillance Specialist by email: Elekta_Global_PMS@elekta.com. |
| Quantity | 12 units |
| Distribution | US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182076 | Elekta Unity Elekta Limited, Dec 4, 2018 |