Recall Z-0841-2013— Elekta, Inc.

Name: FDA recall Z-0841-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-11

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-02-11, terminated 2014-01-21. It names one FDA 510(k) clearance: K110730. Product: Monaco RTP System. Radiation treatment planning.. Reason: The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-11
Terminated: 2014-01-21
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. Radiation treatment planning.

Reason for recall

The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.

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