The FDA has posted 183 enforcement recalls of interventional fluoroscopic x-ray system devices since 2025, including 20 Class I (most serious) recalls. Most recent report: Aug 19, 2026.
Firmware issue potentially leading to loss of geometry movements.
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead…
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss…
Due to a defective circuit board that overheats
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Interventional Fluoroscopic X-Ray System”). Informational only — verify against the FDA before acting.