Interventional Fluoroscopic X-ray System

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058.

Firmware issue potentially leading to loss of geometry movements.

Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*,

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 of geometry movements that may lead to delay of therapy and procedural complications

Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Intervention

Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 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 to delay of therapy and procedural complications.

Philips Allura under the following System Descriptions and corresponding model numbers:

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Philips Azurion under the following System Descriptions and corresponding model numbers:

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400.

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Brand Name: OXOS Medical, Inc

Due to a defective circuit board that overheats

ARTIS icono biplane. Model Number: 11327600.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

ARTIS icono ceiling. Model Number: 11328100.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

ARTIS icono floor. Model Number: 11327700.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.