Recall Z-0439-2014— Varian Medical Systems, Inc.

Name: FDA recall Z-0439-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-24

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2013-10-24, terminated 2016-01-13. It names 2 FDA 510(k) clearances: K132705, K131807. Product: C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.. Reason: This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation..

Recalling firm: Varian Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-24
Terminated: 2016-01-13
Firm location: Palo Alto, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K132705 — UNIQUEVarian Medical Systems, Inc.·cleared 2013-10-31
K131807 — HIGH ENERGY LINEAR ACCELERATORVarian Medical Systems, Inc.·cleared 2013-10-11

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

C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Reason for recall

This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.

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