Recall Covers 21,352 Fluoroscopy Systems Worldwide
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 procedures. The FDA posted 22 separate recall notices on March 27, 2026, and Philips estimates that approximately 21,352 units are affected worldwide.
The problem is tied to the wired foot switch on the systems, which may fail to initiate X-ray imaging or trigger imaging inconsistently. The FDA attributes the issue to device design. In interventional procedures, where real-time fluoroscopy is essential for guiding catheters, guidewires, and implantable devices, an imaging activation failure can have direct clinical consequences.
Philips’ Guidance to Hospitals
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 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 spokesperson stated. “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.”
Global Distribution and Recall Severity
Affected units were distributed nationwide across the United States and widely internationally, spanning Europe, Asia, the Middle East, Africa, and the Americas. 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.
Despite the “Class II” classification, the sheer number of affected units (over 21,000) makes this one of the largest recent recalls in medical imaging equipment. The geographic breadth also means that cath labs and interventional suites on virtually every continent need to verify whether their equipment is on the list.
Impact on Imaging Department Operations
For departments using Azurion and Allura systems, the immediate impact is operational. The requirement for daily pre-procedure checks adds time to room preparation. In high-volume services such as cath labs and neuro-interventional suites, any delay can affect case scheduling.
More concerning is the scenario where the foot switch fails during a procedure. In a coronary angioplasty or emergency embolization, momentary loss of fluoroscopy could force the team to pause the procedure or continue blindly for several seconds, which is unacceptable from a safety standpoint. Services should ensure a documented contingency plan exists for this eventuality.
Context: Recalls in Medical Imaging Equipment
This recall fits into a broader trend of regulatory vigilance over medical imaging equipment. The FDA has been increasing its scrutiny of radiological devices, covering both traditional hardware and AI-based software. For institutions, the message is clear: preventive maintenance programs and post-market surveillance need to be robust, and clinical engineering teams must maintain direct channels with manufacturers.
Philips stated it will install corrective measures on affected units throughout 2026 and that customers may continue using the systems in accordance with their instructions for use and the guidance in the notice. No device removals have been announced.
What to Do If Your Facility Has These Systems
Facility managers and clinical engineers should immediately verify whether their Azurion, Allura Xper, Allura Centron, or Allura CV20 systems appear on the FDA recall list. Recommended actions include implementing daily foot switch checks before each use, documenting any activation irregularities, contacting the local Philips representative to confirm receipt of the notice and schedule the correction, and establishing a contingency protocol for foot switch failures during procedures.
Source: DOTmed Healthcare Business News
