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.
This recall has been terminated (originally issued October 23, 2012).
- Company
- Elekta, Inc.
- Recall Initiated
- August 21, 2012
- Posted
- October 23, 2012
- Terminated
- November 3, 2014
- Recall Number
- Z-0118-2013
- Quantity
- 52 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
None as the product is software
Root Cause
Software design
Action Taken
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.