Recall Z-0181-2016— Elekta, Inc.

Name: FDA recall Z-0181-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-16

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2015-10-16, terminated 2017-04-04. It names one FDA 510(k) clearance: K151233. Product: Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Reason: Unintended update of Dose and MU and Incorrect Assignment of Bolus..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-16
Terminated: 2017-04-04
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K151233 — MonacoImpac Medical Systems, Inc.·cleared 2015-07-07

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

Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Reason for recall

Unintended update of Dose and MU and Incorrect Assignment of Bolus.

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