Recall Z-0050-2018 ยท MUJ System, Planning, Radiation Therapy Treatment
Nucletron BV
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treat
| Date | Aug 10, 2017 |
| Status | Terminated |
| Reason | Incorrect source step size may occur in the software plans |
| Root cause | Software design |
| Action | Elekta sent an Field Safety Notice notification dated August 2017, and was emailed to customers on August 10, 2017, informed users of the issue and workarounds that can be used to avoid the issue.The user is informed the issue will be resolved in a fix which will be released by the end of February 2018. Once released, the firm will proactively reach out to all affected customers to arrange a time to install the fix. An acknowledgement form was enclosed which the user was to complete to indicate they have read and understood the notice and accept implementation of any given recommendation |
| Quantity | 89 customer sites have the affected software |
| Distribution | Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132816 | ONCENTRA BRACHY Nucletron B.V., Jun 13, 2014 |