Recall Z-0987-2017— Elekta, Inc.

Name: FDA recall Z-0987-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-23

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2016-12-23, terminated 2021-07-16. It names one FDA 510(k) clearance: K121448. 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.".

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Terminated: 2021-07-16
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K121448 — ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHYElekta Inc. D/B/A Nucletron Corporation·cleared 2012-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.