Recall Z-0118-2013 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
| Date | Oct 23, 2012 (initiated Aug 21, 2012) |
| Status | Terminated |
| Reason | During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages. |
| Root cause | Software design |
| Action | Nucletron sent a Customer Information Bulletin 555.00248 to all affected customers. The bulletin identified the product, problem, and actions to be taken by the customers. The bulletin contained information on how an incorrect dose association can be prevented by not renumbering beams during recalculation. A Read Confirmation Form was included for customers to complete and return. Contact your local Nucleton Service Representative for questions regarding this notice. |
| Quantity | 52 units |
| Distribution | Nationwide Distribution-including the states of AL, CA, DC, KS, LA, MO, NB, NY, NC, ND, OH, OR, PA, RI, SC, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081281 | OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) Nucletron Corporation, May 20, 2008 |