FDA recall Z-0719-2023

Product

Oncentra Brachy radiation therapy planning system software.

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-12-05

Report date

2022-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2023