{"id":18075,"date":"2026-06-08T05:12:53","date_gmt":"2026-06-08T08:12:53","guid":{"rendered":"https:\/\/rtmedical.com.br\/tmp-en-1780906372280\/"},"modified":"2026-06-08T05:13:01","modified_gmt":"2026-06-08T08:13:01","slug":"fda-recall-philips-integris-allura-fluoroscopy","status":"publish","type":"post","link":"https:\/\/rtmedical.com.br\/en\/fda-recall-philips-integris-allura-fluoroscopy\/","title":{"rendered":"FDA Recalls Some Philips Integris-Allura Fluoroscopes"},"content":{"rendered":"

The U.S. Food and Drug Administration has classified a field correction involving certain Philips Integris-Allura interventional fluoroscopic X-ray systems as a Class II recall. The reason: a part in the X-ray tube cooling circuit can degrade over time and compromise system performance.<\/p>\n

\"Philips
The FDA classified the Integris-Allura correction as a Class II recall. (Illustrative image)<\/figcaption><\/figure>\n

What triggered the recall<\/h2>\n

Identified as Event ID 98801 and Recall Number Z-2229-2026, the action 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.<\/p>\n

According to the FDA notice, the issue lies in 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 inside the cooling unit.<\/p>\n

Why it matters in clinical practice<\/h2>\n

Integris-Allura systems are angiography and fluoroscopy platforms used in interventional procedures \u2014 from interventional cardiology to vascular radiology. They produce real-time X-ray images to guide catheters, stents and other devices inside the body. The X-ray tube is the heart of this equipment and runs under heavy thermal load, which makes the cooling circuit a critical item for both safety and image quality.<\/p>\n

Oil is essential to keep the X-ray tube within its operating temperature range. If a leak reduces cooling capacity, oil flow can fall below a predefined threshold. In that case, the system automatically switches to low-dose fluoroscopy and displays the message: “Low load fluoroscopy flavor selected: Tube cooler problem.”<\/p>\n

For a cath lab or interventional radiology team, that means degraded image quality in the middle of a procedure \u2014 a serious problem when catheters are being navigated in real time. Philips also warned that restarting the system will not resolve the condition, requiring service intervention. The manufacturer has been investing in tools to cut dose without losing quality, as we covered when detailing Philips SmartIQ in cardiac catheterization<\/a>.<\/p>\n

It is worth clarifying that the automatic switch to low-dose fluoroscopy is, in itself, a protective fallback rather than a radiation hazard. The real concern is image adequacy: insufficient quality during an interventional case can prolong the procedure, prompt repeat acquisitions or even force a conversion to an alternative approach \u2014 each of which carries its own clinical and safety implications for the patient on the table.<\/p>\n

Affected equipment and reach<\/h2>\n

The FDA attributed the recall to a component design or selection issue. Affected products include several Integris-Allura and Integris CV configurations, in both monoplane and biplane versions. In all, the company reported 25 affected units \u2014 11 in the United States and 14 outside the country.<\/p>\n

Although the number of devices is small, they were distributed nationwide in the U.S. and internationally across more than 100 countries. As of the notice’s publication, the FDA listed no injuries or deaths tied to the issue, which helps explain the Class II classification \u2014 a category reserved for situations where use may cause temporary or reversible harm, with a low probability of serious consequences.<\/p>\n

What Philips advises<\/h2>\n

On April 28, Philips distributed urgent medical device correction letters to customers. The company instructed facilities to notify all users of the affected systems, retain the notice with the equipment documentation, and report any occurrence of the issue to a local representative. Organizations that transferred affected equipment to another facility were also asked to forward the notice and notify Philips.<\/p>\n

The manufacturer said it plans to replace the deaeration hose in all affected CU3101 cooling units beginning in the first quarter of 2027. Local representatives will contact customers to schedule service visits once replacement parts become available.<\/p>\n

The gap between identifying the problem and the scheduled replacement is worth noting: while parts are pending, the practical guidance is to watch for the error message and call technical support at the first sign of degraded cooling performance, avoiding starting a procedure under suboptimal conditions.<\/p>\n

Context and outlook<\/h2>\n

Imaging-equipment recalls are part of routine device vigilance and do not always signal immediate patient risk. Even so, the case underscores the importance of preventive maintenance and of fast communication channels between manufacturer and service. For hospital managers, it is worth checking serial numbers, manufacturing dates and maintenance contracts to ensure the scheduled replacement does not disrupt the procedure calendar. The continuous modernization of platforms such as the Azurion and Integris lines, the focus of other recent Philips medical-imaging launches<\/a>, usually goes hand in hand with this kind of lifecycle adjustment.<\/p>\n

In countries like Brazil, imported equipment of this type goes through registration with the health regulator, and corrective actions ordered abroad usually trigger equivalent local notices. Services running Philips interventional platforms should track both international alerts and local notifications, since the installed base typically spans several different generations of these interventional systems.<\/p>\n

Source:<\/strong> DOTmed News<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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