Recall Z-0784-2021— Accuray Incorporated

Name: FDA recall Z-0784-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-10

Class II · Terminated

Class II FDA medical device recall by Accuray Incorporated, initiated 2020-12-10, terminated 2022-09-26. It names one FDA 510(k) clearance: K121934. Product: TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.. Reason: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose..

Recalling firm: Accuray Incorporated
Classification: Class II
Status: Terminated
Initiated: 2020-12-10
Terminated: 2022-09-26
Firm location: Madison, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K121934 — TOMOTHERAPY TREATMENT SYSTEMAccuray Incorporated·cleared 2012-08-29

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

TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

Reason for recall

"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

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