Recall Z-0719-2023 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Oncentra Brachy radiation therapy planning system software.
| Date | Dec 15, 2022 (initiated Dec 5, 2022) |
| Status | Open, Classified |
| Reason | A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling |
| Root cause | Software design |
| Action | Elekta issued an Important Field Safety Notice 806-01-BTP-003 dated November 2022 to all affected customers on 12/5/2022 via email. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The notice is to be posted in a place accessible to all users until this action is closed. Appropriate personnel working with the product are to be advised of the content of the letter. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta r |
| Quantity | 336 systems |
| Distribution | Distribution US nationwide, including Puerto Rico. There was no military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132816 | ONCENTRA BRACHY Nucletron B.V., Jun 13, 2014 |