Recall Z-1091-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand 52-leaf Millennium MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and
| Date | Feb 23, 2012 (initiated Jan 16, 2012) |
| Status | Terminated |
| Reason | When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose. |
| Root cause | Device Design |
| Action | Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides recommended actions when planning and treating dynamic fields on the 52 leaf MLCs. Contact the Help Desk at 1-888-827-4265 for questions regarding this recall. |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Canada, China, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Singap |
| FDA record | Open on fda.gov |