Recall Z-0821-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc.
Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
| Date | Dec 28, 2010 (initiated Jul 20, 2010) |
| Status | Terminated |
| Reason | The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as Dynamic Arc therapy plans. If this occurs, the VMAT plan will not be recognized. This issue affects Trilogy machines with the Rapid Arc Treatment delivery option. |
| Root cause | Software design |
| Action | Varian issued Urgent Medical Device Correction letters dated July 20, 2010 to its direct consignees, informing them of the affected product and providing instructions on the actions to be taken. These instruction include: if the unit does not display "RapidArc" or "VMAT" under Treatment Type during dose delivery, discontinue use of the device and call Varian service. Varian Service Help Desk can be contacted at 1-888-827-4265. |
| Distribution | Worldwide Distributiuon: Throughout the US, and the countries of Australia, Canada, China, Japan, and New Zealand, and in the regions of North and Latin America, Europe, and South East Asia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072916 | TRILOGY SYSTEM WITH RAPIDARC Varian Medical Systems, Inc., Nov 9, 2007 |