C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear acceler
FDA device recall Z-0439-2014 · posted 2013-12-03 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
- Action taken
- Varian sent an Urgent Medical Device Correction letter, P/N CP-05645 Rev D dated October 24, 2013 to their affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated all affected sites will be contacted by Varian representatives to schedule an upgrade to their devices. Questions may be directed to 888-827-4265 for USA and Canada. Europe +41 41 749 8844
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3,809 devices
- Distribution
- Worldwide Distribution - USA Nationwide and in the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bosnia and Herzegovina, Brazil, Bulgaria, C
- Date initiated
- 2013-10-24
- Date posted
- 2013-12-03
- Date terminated
- 2016-01-13
- 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 |
|---|---|---|
| UNIQUE (K132705) | Varian Medical Systems, Inc. | 2013-10-31 |
| HIGH ENERGY LINEAR ACCELERATOR (K131807) | Varian Medical Systems, Inc. | 2013-10-11 |