Recall Z-2712-2016— Elekta, Inc.

Name: FDA recall Z-2712-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-18

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2016-08-18, terminated 2025-02-28. It names one FDA 510(k) clearance: K110730. Product: Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Reason: In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-18
Terminated: 2025-02-28
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K110730 — MONACO RTP SYSTEMComputerized Medical Systems, Inc.·cleared 2011-06-24

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 Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Reason for recall

In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.

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