Recall Z-1325-2013— Varian Medical Systems, Inc. Oncology Systems

Name: FDA recall Z-1325-2013
Creator: U.S. Food and Drug Administration
Published: 2011-05-31

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc. Oncology Systems, initiated 2011-05-31, terminated 2013-05-15. It names one FDA 510(k) clearance: K100890. Product: Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.. Reason: Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control..

Recalling firm: Varian Medical Systems, Inc. Oncology Systems
Classification: Class II
Status: Terminated
Initiated: 2011-05-31
Terminated: 2013-05-15
Firm location: Palo Alto, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K100890 — VARIAN HIGH ENERGY LINEAR ACCELERATORVarian Medical Systems·cleared 2010-07-13

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

Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Reason for recall

Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.

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