Elekta, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0841-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
Product Description:

Monaco RTP System. Radiation treatment planning.

Product Classification:

Class II

Date Initiated: February 11, 2013
Date Posted: February 27, 2013
Recall Number: Z-0841-2013
Event ID: 64328
Reason for Recall:

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

Status: Terminated
Product Quantity: 13
Code Information:

Versions 3.20.00 and 3.20.01

Distribution Pattern:

Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated