FDA issues recall of Philips interventional imaging system due to safety risks

The U.S. Food and Drug Administration has issued a recall of interventional imaging systems manufactured by Philips due the potential loss of X-ray function mid-procedure. 

The Class 2 recall, posted on June 12, applies to Philips Azurion Systems, which are used for a myriad of interventional procedures. According to the FDA’s website, a malfunction in communication between the system’s software and the X-ray generator firmware has been reported to cause loss of imaging functionality. When this occurs, there is the risk of delays in therapy, which could be be life-threatening depending on the procedure. 

“The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings),” the recall states. 

Philips sent urgent medical device correction messages to affected customers on May 28. Those letters provide guidance to users of the system on how to avoid the aforementioned communication errors. Customers are urged to keep the document within an IR suite until the issue is resolved, and to report any incidents to Philips. 

The manufacturer is addressing the error by updating the software of all the affected systems. For those featuring an Interventional Workspot and/or EchoNavigator, Philips will upgrade perform an upgrade.

There are approximately 9,700 Azurion systems in operation globally, around 2,300 of which are used in the U.S. 

For more information, view the official recall here.