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Terminated

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.

FDA Recall Z-0987-2017 · Posted None

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2016-12-23
Date Terminated2021-07-16
Product Quantity433

Reason for Recall

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

Firm Action

Elekta sent an Urgent Important Safety Notification letter dated December 23, 2016 to affected customers. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The letter included an acknowledgement form to be returned to Elekta.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121448ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHYElekta Inc. D/B/A Nucletron Corporation · 2012-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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