The U.S. Food and Drug Administration has added thousands of Philips interventional imaging systems, specifically the Allura and Azurion fluoro systems, to its medical device recall list due to potential cooling issues. The problem lies in the deaeration hoses in the X-ray tube cooling units, which may degrade over time, leading to oil leaks that can affect the systems' cooling performance. This Class 2 recall applies to systems manufactured between February 2016 and May 2020, impacting nearly 10,000 devices globally. Philips has notified affected customers, indicating that the issue cannot be quickly fixed in-house and that replacement components will begin to be installed in the first quarter of 2027. Class 2 recalls indicate potential medical harm, although the likelihood of serious consequences is considered remote.
Wed, 27 May 2026 17:54:57 GMT | Radiology Business