Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 121–132 of 176 recalls
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems.…
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems.…
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware.…