Elekta, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0965-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Monaco Radiation Treatment Planning (RTP) System

Product Classification:

Class II

Date Initiated: February 8, 2019

Date Posted: March 6, 2019

Recall Number: Z-0965-2019

Event ID: 82072

Reason for Recall:

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

Status: Terminated

Product Quantity: 14 devices

Code Information:

Software version 5.40

Distribution Pattern:

Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated