Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0112-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Product Classification:

Class II

Date Initiated: September 15, 2015

Date Posted: October 14, 2015

Recall Number: Z-0112-2016

Event ID: 72221

Reason for Recall:

Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.

Status: Terminated

Product Quantity: 154 units

Code Information:

Software Version 5.10.00

Distribution Pattern:

Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.

Voluntary or Mandated:

Voluntary: Firm initiated