Elekta, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2409-2019)

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 System (RTP) System

Product Classification:

Class II

Date Initiated: August 23, 2019

Date Posted: September 4, 2019

Recall Number: Z-2409-2019

Event ID: 83604

Reason for Recall:

Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.

Status: Terminated

Product Quantity: 49 units

Code Information:

Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00

Distribution Pattern:

Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated