Recall Z-0439-2014 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc.
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indic
| Date | Dec 3, 2013 (initiated Oct 24, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 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, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecu |
| FDA record | Open on fda.gov |