C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. Device is a radiation Therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are inteded for therapy of lesions such as arteriovenous malformations, primary tumors and metastatses. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.
This recall has been terminated (originally issued January 18, 2011).
- Recall Initiated
- October 8, 2009
- Posted
- January 18, 2011
- Terminated
- February 24, 2012
- Recall Number
- Z-0910-2011
- Quantity
- 5208 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Product may deliver radiation treatment to areas larger than intended,to healthy tissue.
Distribution
Worldwide Distribution
Lot / Code Info
to be added.
Root Cause
Nonconforming Material/Component
Action Taken
Varian sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 8, 2009, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Varian recommended to consignees that test runs be performed prior to actual patient treatment to ensure that the entire system is behaving as intended and that appropriate quality assurance procedures should be followed prior tothe delivery of any treatment plan involving radiation therapy. Operators should monitor the patient and the treatment console continuously during treatment. For questions call USA and Canada - 1-888-827-4265, Europe +41 41 749 8844.