The U.S. Food and Drug Administration (FDA) has issued a Class 2 recall of Philips Healthcare's Azurion interventional fluoroscopy systems.
The recall is due to instances Philips has identified where x-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
The company sent urgent medical device correction letters to customers on March 3, urging them to circulate the letter to all users; to perform a daily check before starting the day's first procedure; to report any foot switch activation issues to a local Philips representative; and to keep the letter with documentation of the system until Philips corrects the problem.
