Philips
(NYSE: PHG)
issued an urgent field safety notice regarding its Allura and Azurion image-guided therapy systems.
The notice warns of an issue that may occur due to forces applied during the movement of the C-Arc for Allura and Azurion. Philips’ image-guided therapy systems may experience loosening or breaking in their FlexMove carriage as a result. Cracks may also occur in the FlexMove carriage.
If FlexMove rail fixation bolts become loose or broken, cracks appear and a range of issues may occur. That includes the stopping of the C-Arc’s transversal movements due to false collision detections from additional friction. The issue may also disable manual movement because of the added friction. Abnormal noise, unstable suspension and falling of the C-Arc may also occur.
Loss of the mechanical movements of the C-Arc during a procedure could lead to a delay and/or abortion of the procedure. Although the likelihood of serious injury or death remains remote, Philips said it can’t be ruled out. The falling or dropping of the C-Arc could cause different levels of injury.
This issue affects all Azurion and Allura Xper systems installed with the FlexMove option.
Philips received 14 complaints related to 11 systems reporting loose and/or broken bolts. In three cases, users identified cracks. None of these instances including the falling or dropping of the C-Arc assembly and Philips received no reports of harm to patients or bystanders.
What Philips plans to do
Philips plans to inspect all affected systems, checking for cracks and secure bolts. The company intends to replace any loose and broken bolts.
According to Philips, the inspection “is of great importance.”
If, during inspection, it proves not possible to replace loose or broken bolts, or if the inspection uncovers cracks, Philips intends to plan for the replacement of affected bolts and/or the entire carriage.
Based on available information, systems may safely continue use for at least one year following these actions. Philips said its technical experts continue to work on a permanent solution.
More about the Allura and Azurion systems
Azurion systems perform image guidance in diagnostic, interventional and minimally invasive surgical procedures. It covers areas such as vascular, non-vascular, cardiovascular and neurological procedures. Cardiac imaging applications for Aurion include diagnostics, interventional and minimally invasive procedures.
Allura systems perform vascular, cardiovascular and neurovascular imaging applications. This includes peripheral, cerebral, thoracic and abdominal angiography. It also covers PTAs, stent placements, embolizations and thrombolysis.
Both systems can be configured with the FlexMove carriage. FlexMove enables the parking of the stand in a stand-by position before moving it into position when needed during the procedure. If installed, FlexMove allows the stand to move longitudinally and transversely on ceiling-mounted rails.