Recall Z-0987-2017 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
| Date | Dec 23, 2016 |
| Status | Terminated |
| Reason | Cross profile for Varian 60 degree wedge shows "horns." |
| Root cause | Software design |
| Action | Elekta sent an Urgent Important Safety Notification letter dated December 23, 2016 to affected customers. 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 letter included an acknowledgement form to be returned to Elekta. |
| Quantity | 433 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX, and the countries of Angola, Argentina, Armenia, Australia, Austria, Barbados, Belarus, Brazil, Bulgaria, Canada, China Columbia, Curacao, Czech Republic, Denmark, Finland, France, Germany, Greece, Ho |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121448 | ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY Elekta Inc. D/B/A Nucletron Corporation, Jul 2, 2012 |