Two interventional fluoroscopic X-ray systems were recalled in separate Class II events due to safety issues affecting image acquisition and mechanical movement, according to FDA notices posted Jan. 27.
The first recall, initiated Dec. 19, involves 332 units of the Alphenix INFX-8000V, a ceiling-suspended system in which fixing screws may loosen — potentially disabling lateral movement, generating abnormal noise or triggering sensor errors. Customers were instructed to stop using the system if malfunctions occur and contact service teams.
The second recall, initiated Dec. 29, affects five units of Siemens’ Luminos Q.namix T system with software version VB10D-SP02. The system may fail to apply automatic horizontal flips to ortho images and, in certain cases, process an image from a previous patient during single-image acquisition. A software update is scheduled for release in the first quarter of 2026.
Both issues were addressed through urgent medical device correction letters. The recalls remain open under the FDA.
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