RecallRadar

FDA Device recall Z-0987-2017

Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiatio…

On 2017-01-18 the FDA classified a Class II recall of Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiatio… by Elekta, citing cross profile for Varian 60 degree wedge shows "horns.".

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0987-2017
ClassificationClass II
Statusterminated
Initiated2016-12-23
Published2017-01-18
Last updated2026-09-13 11:54 UTC
CompanyElekta
DistributionUS

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.

Reason

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

Identifiers

code_infoAll software builds

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0987-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.