Philips Safety Alert on Azurion/Allura Devices

Philips has issued an urgent field safety notice about its Azurion and Allura Xper systems installed with the FlexMove option, which could pose a risk for patients and bystanders. It says that “due to the forces applied during the movement of the C-Arc of the Azurion and Allura systems, the bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the FlexMove Carriage.” Loose or broken bolt could impede the movement of the C-Arc or the device could drop or fall, causing patient harm, the notice says. The company says it will inspect all units and replace any loose or broken bolts.

The Azurion series devices are intended for use to perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures. The Allura Xper series devices are intended to perform vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.