Varian Medical Systems Oncology Systems
Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.
| Date | Jan 11, 2011 (initiated Jan 19, 2010) |
| Status | Terminated |
| Reason | There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly. |
| Root cause | Other |
| Action | Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail receipt on January 19, 2010, to all direct consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to have maintenance personnel perform the recommended measurements as described in the Varian Customer Technical Bulletin. Ensure that all measurements made as part of the procedure are recorded in the 'wear table' that is part of the procedure. Previous wear measurements should be compared to new measurements and any large increase in wear should be |
| Distribution | Worldwide Distribution including USA, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada. |
| FDA record | Open on fda.gov |