Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0987-2017

December 23, 2016

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 76085
Status
Terminated
Classification
Class II
Quantity
433
Official record key
device-enforcement:Z-0987-2017

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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