Recall Z-0118-2013— Elekta, Inc.

Name: FDA recall Z-0118-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-21

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2012-08-21, terminated 2014-11-03. It names one FDA 510(k) clearance: K081281. Product: Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.. Reason: During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-21
Terminated: 2014-11-03
Firm location: Norcross, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K081281 — OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)Nucletron Corporation·cleared 2008-05-20

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 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.

Reason for recall

During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.

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