Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Alto, CA
This recall has been terminated (originally issued February 15, 2008).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- October 2, 2007
- Posted
- February 15, 2008
- Terminated
- May 17, 2011
- Recall Number
- Z-0720-2008
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect Software Validation- The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.
Distribution
Worldwide Distribution
Lot / Code Info
Serial Numbers: All
Root Cause
Software design
Action Taken
An Urgent Medical Device Correction letter was distributed October 2, 2007, to all direct consignees, informing them that the ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery will not be recognized properly by the System. The firm provided corrective instructions and informed consignees that a product modification will be developed to resolve the issue. A Varian Service Representative will be scheduling a visit to upgrade the application.