Recall Z-0719-2023— Elekta, Inc.

Name: FDA recall Z-0719-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-05

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2022-12-05. It names one FDA 510(k) clearance: K132816. Product: Oncentra Brachy radiation therapy planning system software.. Reason: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling.

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-05
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K132816 — ONCENTRA BRACHYNucletron B.V.·cleared 2014-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.