—#113697

Product

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.

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081281
Affected lot / code info: None as the product is software

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern: Nationwide Distribution-including the states of AL, CA, DC, KS, LA, MO, NB, NY, NC, ND, OH, OR, PA, RI, SC, TX, and WA.

Timeline

Recall initiated: 2012-08-21
Posted by FDA: 2012-10-23
Terminated: 2014-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113697. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.