Recall Z-1665-2023 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
| Date | May 30, 2023 (initiated May 5, 2023) |
| Status | Open, Classified |
| Reason | A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 |
| Root cause | Under Investigation by firm |
| Action | Elekta notified customers, via email, on 05/05/2023. Customers were instructed that Elekta will contact each impacted customer to perform an onsite inspection of the power supply unit and replace as needed. Customers were asked to complete and return the Acknowledgement Form. |
| Quantity | 46 units |
| Distribution | Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Elekta Limited, Jun 11, 2021 |