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Terminated

Clinac Linear Accelerators; Varian Medical Systems, Palo Alto, CA. Radiation Therapy intended to deliver megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy.

FDA Recall Z-2893-2011 · Posted 2011-07-28

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-05-24
Date Terminated2012-03-14
Product Quantity278

Reason for Recall

The throat cover on the High Energy Clinac may detach if not properly installed and possibly strike a patient.

Firm Action

Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides directions on how to re-install the gantry center throat cover. Customers can contact their Varian Customer Support Manager at 1-888-827-4265 for further clarification.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution-including USA (nationwide)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100890VARIAN HIGH ENERGY LINEAR ACCELERATORVarian Medical Systems · 2010-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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