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Elekta, Inc. recalls Oncentra Brachy radiation therapy planning system software.
Recalled December 21, 2022 · FDA recall Z-0719-2023 · Elekta
Hazard
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling · FDA Class II
Units
336 systems
Sold at
Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
Description
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Product
Oncentra Brachy radiation therapy planning system software.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →