The FDA has posted 176 enforcement recalls of interventional fluoroscopic x-ray system devices since 2025, including 20 Class I (most serious) recalls. Most recent report: Jul 8, 2026.
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
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without gene…
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.