Recall Z-2978-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated.
| Date | Aug 10, 2011 (initiated May 26, 2011) |
| Status | Terminated |
| Reason | On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions. |
| Root cause | Device Design |
| Action | Varian Medical Systems sent an "Urgent Medical Device Correction-Urgent Field Safety Notice" letter dated May 26, 2011 to all affected customers. ***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.*** The letters identifies the product, describes the problem and provides recommendations. Varian recommends maintenance only be performed by qualified personnel with appropriate training, always verify collimator calibration and anytime a collimator posthion readout calibration is performed, and alw |
| Quantity | 5685 |
| Distribution | Worldwide Distribution: Nationwide (USA) Distribution and the countries of; Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Belorussia, Bolivia, Bosnia and Herzegoniva, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Rep., Denmar |
| FDA record | Open on fda.gov |