Recall Z-0181-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators. Manufactured by Varian Medical System, Palo Alto, CA. Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
| Date | Nov 9, 2011 (initiated Sep 9, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 ASSOC |
| Quantity | 5823 devices |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |