Elekta, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0076-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups

Product Classification:

Class II

Date Initiated: September 29, 2016

Date Posted: October 19, 2016

Recall Number: Z-0076-2017

Event ID: 75303

Reason for Recall:

When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.

Status: Terminated

Product Quantity: 365

Code Information:

Software Builds 5.10 and 5.20

Distribution Pattern:

Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI. Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Portugal, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Zimbabwe.

Voluntary or Mandated:

Voluntary: Firm initiated