Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0181-2016)

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

Product Classification:

Class II

Date Initiated: October 16, 2015

Date Posted: November 4, 2015

Recall Number: Z-0181-2016

Event ID: 72424

Reason for Recall:

Unintended update of Dose and MU and Incorrect Assignment of Bolus.

Status: Terminated

Product Quantity: 154

Code Information:

Software Version 5.10.01

Distribution Pattern:

CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated