Recall Z-3052-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue an
| Date | Aug 22, 2011 (initiated Jun 6, 2011) |
| Status | Terminated |
| Reason | When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose. |
| Root cause | Device Design |
| Action | Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 6, 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 describes various jaw position recommendations to be followed when planning and treating dynamic fields on the HD120 MLC. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice. |
| Quantity | 173***12-20-12 AMENDED TO: 106 units*** |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071992 | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) Varian Medical Systems, Aug 15, 2007 |