Recall Z-1712-2015 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
| Date | Jun 4, 2015 (initiated May 21, 2015) |
| Status | Terminated |
| Reason | Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. |
| Root cause | Other |
| Action | Important User Notice, 806-03-BTP-001, was distributed to customers on 5/21/2015, A software patch is in development and is expected to be released end of November, 2015. Elekta service will work with customers to implement the patch on affected devices within 6 months of the patch release. |
| Quantity | 351 |
| Distribution | AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong, |
| FDA record | Open on fda.gov |