Varian brand C Series Clinics (Includes Trilogy, and Novalis Tx), Model Numbers: H14, H26, H27, H29, Distributed by and/
FDA device recall Z-1001-2011 · posted 2011-01-31 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- A circuit design anomaly whereby a faulty balance potentiometer can lead to an undetected electron beam asymmetry.
- Action taken
- The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 1, 2009 via Federal Express to consignees/customers. The letter described the product, problem and actions to be taken by the customers and the firm. The customers were instructed to perform a verification of field symmetry on electron beam energies to determine the threshold and report any field symmetry issues to their local Varian service office for attention. The firm, Varian, is developing new functionality to detect the symptoms of this component failure condition under all conditions of electron beam operations and asserting a beam interlock if it is detected. Note: Varian indicated until the solution can be developed, they will conduct an audit of installed Clinacs to identify those the suspect "blue" electron beam balance potentiometers installed, and will execute a program of prophylactic replacement of these potentiometers. If you require further clarification, please contact your local Varian Customer Support District or Regional Manager at phone: USA and Canada-1-888-VARIANS (888-827-4265); Europe- +41 41 749-8844 or email support-emea@varian.com; North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; South East Asia: seasia.apps.helpdes@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.apps.helpdesk@varian.com; Latin America: soporte.al@varian.com; Internet: Oncology Systems - www.myvarian.com; Varian Medical Systems -www.varian.com
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 4411
- Distribution
- USA and countries including: Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bolivia, Brazil, Canada, Chile,, China, Columbia, Costa Rica, Czech Republic,
- Date initiated
- 2009-12-01
- Date posted
- 2011-01-31
- Date terminated
- 2012-03-14
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY MX (K092871) | Varian Medical Systems, Inc. | 2009-11-30 |
| TRILOGY SYSTEM WITH RAPIDARC (K072916) | Varian Medical Systems, Inc. | 2007-11-09 |