Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Me
FDA device recall Z-0821-2011 · posted 2010-12-28 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- 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.
- Date initiated
- 2010-07-20
- Date posted
- 2010-12-28
- Date terminated
- 2011-07-18
- Location
- Palo Alto, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY SYSTEM WITH RAPIDARC (K072916) | Varian Medical Systems, Inc. | 2007-11-09 |