Recall Z-2383-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indi
| Date | Sep 14, 2012 (initiated Aug 14, 2012) |
| Status | Terminated |
| Reason | Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-dose of the intended target volume. |
| Root cause | Nonconforming Material/Component |
| Action | Varian sent an "URGENT MEDICAL DEVICE CORRECTION URGENT FIELD SAFETY NOTICE" dated August 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-888-827-4265 for questions regarding this recall. |
| Quantity | 221 Units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |