Recall Z-1009-2017— Elekta, Inc.

Name: FDA recall Z-1009-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-21

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2016-12-21, terminated 2021-07-16. It names 2 FDA 510(k) clearances: K151233, K132971. Product: Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Reason: Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-21
Terminated: 2021-07-16
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

2 on FDA's record

K151233 — MonacoImpac Medical Systems, Inc.·cleared 2015-07-07
K132971 — MONACOImpac Medical Systems, Inc.·cleared 2013-11-20

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

Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Reason for recall

Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

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