Elekta, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0987-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.

Product Classification:

Class II

Date Initiated: December 23, 2016

Date Posted: January 18, 2017

Recall Number: Z-0987-2017

Event ID: 76085

Reason for Recall:

Cross profile for Varian 60 degree wedge shows "horns."

Status: Terminated

Product Quantity: 433

Code Information:

All software builds

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX, and the countries of Angola, Argentina, Armenia, Australia, Austria, Barbados, Belarus, Brazil, Bulgaria, Canada, China Columbia, Curacao, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Kenya, Malaysia, Netherlands, Norway, Oman, Peru, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Yemen, Zambia.

Voluntary or Mandated:

Voluntary: Firm initiated