by
Gus Iversen, Editor in Chief | June 05, 2026
The FDA has classified a field correction involving certain Philips Integris-Allura interventional fluoroscopic X-ray systems as a Class II recall after the manufacturer identified a component issue that could affect system performance.
The recall, identified as Event ID 98801 and Recall Number Z-2229-2026, was initiated by Philips Medical Systems Nederland B.V. on April 28, 2026, and posted by the FDA on May 21. The action remains open.
According to
the FDA notice, the issue involves the deaeration hose used in CU3101 X-ray tube cooling units manufactured between February 2016 and May 2020. Philips said the hose may deteriorate over time, potentially causing oil leakage within the cooling unit.
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If oil leakage reduces cooling performance, the X-ray tube’s oil flow can fall below a predefined threshold. In those cases, the system automatically switches to low-dose fluoroscopy and displays the message: “Low load fluoroscopy flavor selected: Tube cooler problem.” Philips noted that restarting the system will not resolve the condition.
The FDA attributed the recall to a component design or selection issue.
Affected products include several Integris-Allura and Integris CV system configurations, including monoplane and biplane models. The company reported that 25 units are affected, including 11 in the United States and 14 outside the U.S.
Philips distributed urgent medical device correction letters to customers on April 28. The company instructed facilities to notify all users of the affected systems, retain the notice with system documentation, and report any occurrence of the issue to a local Philips representative. Organizations that transferred affected equipment to another facility were also asked to forward the notice and notify Philips.
Philips said it plans to replace the deaeration hose in all affected CU3101 cooling units beginning in the first quarter of 2027. Local Philips representatives will contact customers to schedule service visits once replacement parts become available.
The affected systems were distributed nationwide in the U.S. and internationally across more than 100 countries. No injuries or deaths were listed in the FDA recall notice.
