Elekta, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0118-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 21, 2012

Date Posted: October 31, 2012

Recall Number: Z-0118-2013

Event ID: 63405

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.

Status: Terminated

Product Quantity: 52 units

Code Information:

None as the product is software

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.

Voluntary or Mandated:

Voluntary: Firm initiated