Philips issues urgent device correction notice for thousands of imaging units

Philips has issued urgent medical correction letters to users of the company's interventional fluoroscopy units due to issues with the foot switch.  

As such, the Allura and Azurion interventional fluoro series are the subject of a Class 2 recall from the U.S. Food and Drug Administration. Philips has indicated the recall is owed to a design flaw that could prevent X-ray imaging from being initiated when using the wired foot switch; it also could cause it to function intermittently.  

Philips notified affected customers of the issue in early March, also sharing information on signs of potential issues with its devices. The company is urging users to do a quality check of the system daily before deployment. It also is requesting that customers who experience the glitch inform their local Philips representative and keep the letter on hand until the issue is corrected. The recall does not require users to stop operating the systems nor to have them removed from service. 

More than 20,000 affected units could potentially be affected by the faulty switch. These systems are in operation globally, including across the United States.  

The FDA assigns Class 2 recalls for issues that have the potential to “cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” However, no adverse events related to the switch malfunction have been reported. 

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