Elekta, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0719-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Oncentra Brachy radiation therapy planning system software.

Product Classification:

Class II

Date Initiated: December 5, 2022

Date Posted: December 21, 2022

Recall Number: Z-0719-2023

Event ID: 91224

Reason for Recall:

A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

Status: Ongoing

Product Quantity: 336 systems

Code Information:

Version 4.0 and above with Applicator Modeling or Implant Modeling; UDI GTIN numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700.

Distribution Pattern:

Distribution US nationwide, including Puerto Rico. There was no military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated