Recall Z-0182-2022— Elekta, Inc.

Name: FDA recall Z-0182-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-13

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2021-10-13. It names one FDA 510(k) clearance: K132816. Product: Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00. Reason: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-10-13
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 users using version 4.0 and above with Applicator Modeling license 170283-00

Reason for recall

Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

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