Philips Medical Systems has initiated a Class II recall of select Azurion, Allura Xper, Allura Centron and Allura CV20 interventional fluoroscopic X-ray systems after identifying an issue that may prevent imaging from starting or cause intermittent activation during use.

Impacted systems are listed across 22 separate recalls posted by the FDA on March 27, 2026. According to Philips, approximately 21,352 units are impacted worldwide.

The posts from the FDA explain the problem is tied to the wired foot switch on the systems, which may fail to initiate X-ray imaging or may trigger imaging inconsistently. The agency attributes the issue to device design.
Philips has been notifying customers through an “urgent medical device correction” letter outlining interim steps for continued use. Facilities are instructed to perform daily system checks prior to procedures and to report any foot switch activation issues to Philips. The company also advised users to distribute the notice internally, retain documentation with the system, and confirm receipt within 30 days.

"Philips has intensified efforts to strengthen patient safety and quality across the company," a company spokesperson told HCB News. "We are methodically working through product quality at all levels and businesses in a multiyear program. We act fast on post market surveillance signals, proactively issuing corrections, updates or recalls when we identify potential issues."

The affected units were distributed nationwide in the U.S. and widely internationally across Europe, Asia, the Middle East, Africa, and the Americas.

"Customers may continue to use affected systems in accordance with their Instructions for Use (IFU) and the guidance in the notice," the spokesperson said. "To address the issue, Philips will install corrective measures to affected units throughout 2026."

Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious harm is considered remote.

The recall remains open, and no device removals have been announced.

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