Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Philips Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP), Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and MX8000 Dual v. EXP

15 Apr 2014

Medical device manufacturer, Varian, has issued a medical device safety alert concerning C-Series Clinac accelerators equipped with software versions 2.x through 6.x. The affected models are 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX and DHX.

According to the manufacturer, an event has been reported 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.

The manufacturer advises users to take adequate precautions and exercise due care in aspects of position readout accuracy with C-Series Clinac accelerators equipped with the affected software versions. This does not affect the multileaf collimator (MLC).

According to the local supplier, the affected products were distributed in Hong Kong.

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

Posted on 14 April 2014

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