Important Safety Alerts

Important Safety Alerts

Field Safety Notice: Varian C-Series Clinac® or Trilogy, versions 7.x and 8.x

25 Nov 2011

Medical device manufacturer, Varian, has issued an urgent field safety notice concerning C-Series Clinac or Trilogy accelerator, versions 7.x and 8.x.

An event has been reported to Varian involving a C-Series Clinac® accelerator. The event entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. Normal daily quality assurance testing and light field verification detected the discrepancy. Varian has not received any report of misadministration as a result of the discrepancy. Investigation found that a similar issue could arise on the gantry or couch axes. This does not affect the MLC.

According to the local supplier, the affected device has been distributed in Hong Kong. Varian has notified all possibly affected customers in Hong Kong and is continuing to evaluate possible technical solution for this issue.

If you are in possession of the affected products, please contact your supplier for necessary actions.

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