ENS Event | |
|---|---|
04:00 Jul 13, 2017 | |
| Title | Part 21 Notification - Oncentra Software Problem May Cause Unintended Step Size During Brachytherapy Treatment |
| Event Description | On July 13, 2017, a user in France notified Elekta that they discovered a software issue during their Quality Assurance audit of Elekta's Oncentra Brachy software. Elekta investigated and determined a software issue exists in Oncentra software versions 4.5, 4.5.1, and 4.5.2.
On August 11, 2017, Elekta issued an important field safety notice (IFSN) worldwide. The software issue will be resolved in the next issued version of the Oncentra software. See related NRC event numbers 52922 and 52914. Elekta point of contact: Debra Bensen, RSO, debbie.bensen@elekta.com or (770) 670-2518. |
| Where | |
|---|---|
| Elekta Atlanta, Georgia (NRC Region 1) | |
| Organization: | Elekta |
| Reporting | |
| 10 CFR 21.21(d)(3)(i), Failure to Comply or Defect | |
| Time - Person (Reporting Time:+1039.78 h43.324 days <br />6.189 weeks <br />1.424 months <br />) | |
| Opened: | Debra Bensen 11:47 Aug 25, 2017 |
| NRC Officer: | Howie Crouch |
| Last Updated: | Aug 25, 2017 |
| 52926 - NRC Website | |
Elekta with 10 CFR 21.21(d)(3)(i), Failure to Comply or Defect | |
WEEKMONTHYEARENS 529262017-07-13T04:00:00013 July 2017 04:00:00
[Table view]10 CFR 21.21(d)(3)(i), Failure to Comply or Defect Part 21 Notification - Oncentra Software Problem May Cause Unintended Step Size During Brachytherapy Treatment 2017-07-13T04:00:00 | |