Recall Z-3101-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields relation to anatomical and/or fiducial landmarks. Trilogy Mx is intended
| Date | Aug 31, 2011 (initiated Jun 21, 2011) |
| Status | Terminated |
| Reason | Varian has identified a software anomaly in the 3D Match environment, regarding a slight mismatch between CT image and Structures in On-Board Imager w/s. |
| Root cause | Nonconforming Material/Component |
| Action | Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 21, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the 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 letter recommends several user actions. The firm is developing a correction for the issue and will contact customers when the correction is available. Questions regarding this notice may be addressed by contacting the Varian Oncolog |
| Quantity | 2268 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |