Recall Z-0720-2008 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
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
| Date | Feb 15, 2008 (initiated Oct 2, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001643 | VARIS 1.4G Varian Medical Systems, Inc., Jun 23, 2000 |