Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators. Manufactured by Varian Medical System, Palo Alto, CA
FDA device recall Z-0181-2012 · posted 2011-11-09 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode.
- Action taken
- The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated September 9, 2011 to all affected customers via Federal Express with attached instructions. The letter provides the description of problem; references, details, recommended user actions, and varian actions. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** In addition, the letter also states "THIS LETTER IS NOT A SUBSTITUTE FOR THE CAREFUL REVIEW OF ALL USER DOCUMENTATION ASSOCIATED WITH YOUR PARTICULAR EQUIPMENT AND SOFTWARE." If you have any questions, contact Varian Oncology Help Desk at USA and Canada: 1.888.VARIANS (888.827.4265); Europe +41 41 749 8844 and/or Internet: Oncology Systems customer site-www.myvarian.com and Varian Medical Systems public site-www.varian.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 5823 devices
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-09-09
- Date posted
- 2011-11-09
- Date terminated
- 2012-07-24
- 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 |
|---|---|---|
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890) | Varian Medical Systems | 2010-07-13 |
| TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K033343) | Varian Medical Systems, Inc. | 2003-12-23 |