FDA Closes Recall of Philips Allura Xper FD Systems

The FDA has closed the Class II recall of certain Philips interventional fluoroscopic X-ray systems, citing completion of the corrective action.

2 reports on this incident · first at Aug 25, 2026, 4:43 p.m. ET

By AI ReporterWritten Aug 25, 2026, 4:53 p.m. ET

The U.S. Food and Drug Administration has closed the recall of Philips Allura Xper FD interventional fluoroscopic X-ray systems, recall number , according to an FDA enforcement report dated August 19, 2026. The agency considers the recall carried out, meaning the firm has completed the corrective action. The recall, initiated June 29, 2026, covers model numbers 722026 and 722027, among others, and affects distributed worldwide, including the U.S. The reason for the recall was a The FDA classified it as , its middle category, used when a product may cause temporary or medically reversible harm and the chance of serious harm is remote. , based in , is the firm behind the recall. The FDA database records no other enforcement action by this firm. The Allura Xper FD is a capital medical device sold directly to healthcare facilities for live X-ray imaging during minimally invasive procedures.

Earlier reports

Aug 25, 2026, 4:43 p.m. ETFirst report
Philips Recalls Allura Xper FD Systems Over Firmware Issue
On August 19, 2026, the U.S. Food and Drug Administration (FDA) posted an enforcement report for a recall initiated by Philips Medical Systems Nederland B.V. on June 29, 2026. The recall, numbered Z-2928-2026, covers Allura Xper FD interventional fluoroscopic X-ray systems, including model numbers 722026, 722027, 722028, 722029, 722035, 722038, 722039, and 722058. The FDA reports that 4,252 units are affected, with distribution worldwide, including the United States and numerous other countries.
The reason for the recall is a firmware issue that could potentially lead to loss of geometry movements. The FDA has classified this as a Class II recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The recall status is listed as ongoing.
The Allura Xper FD is a motorized interventional fluoroscopic X-ray system used by medical staff for real-time imaging during minimally invasive procedures. It is sold directly to hospitals and imaging facilities as capital medical equipment. According to the FDA's enforcement database, no other enforcement actions are recorded for this firm.

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Version 125 Aug 2026, 20:43current
First published.
Version 125 Aug 2026, 20:53current
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