Azurion R2.1.10 and R2.2.10 systems

Companies: Philips Medical Systems Nederland B.V., Veenpluis 6, Best, Netherlands, 5684 PC.

Philips has identified six software issues affecting Azurion R2.1.10 and R2.2.10 systems that may result in loss of imaging (x-ray) functionality, and/or loss of motorized movement, and/or incorrect image content, and/or loss of data.

Issue 1 - System keeps restarting

when the patient database in the Azurion system's suite PC, which stores metadata about patients, studies, procedures, and series objects, contains more than 50,000 series objects, system functionality becomes unavailable. The Azurion system then initiates a recovery restart, but because the number of series objects remains unchanged, the issue persists and the system repeatedly performs recovery restarts. No message is displayed to indicate this situation.

Issue 2 - AMC triple drive

Due to a firmware issue in the advanced motion controller (AMC) 3-axis drive:

movements of the stand might be slow - when this occurs the message "adjustment of frontal stand is required" is displayed to the user, and 3D scan functionality is not available. The message "rotational scanning is unavailable. Reselect the x-ray protocol" is displayed to the user.

motorized movements of the stand might become unavailable - when this occurs, the message "adjustment of frontal stand is required" is shown to the user.

Issue 3 - C-partition of suite PC running out of free space

The C-drive of the Azurion suite PC may gradually lose available space due to the accumulation of printer spool files.

The windows operating system creates a spool file for each print job and deletes it after successful completion. If a print job fails, the spool files are not removed and accumulate after each system (re)start as Windows retries the job, consuming disk space. When the system (re)starts and the C-drive is full, motorized movements are disabled. The following messages appear on the screen "some geometry movements are not available" and "the geometry is starting. Do not change sid".

Issue 4 - System remains in continuous restart mode after the start-up

Due to a software issue, the license manager (LM) - which verifies installed licenses and enables optional functionality in the Azurion system based on the available licenses - expands the Windows registry database at every system start or restart.

Over time, the registry may grow beyond the maximum size that the LM can load. When this happens, the LM cannot start and the system will enter a continuous reboot loop. The Azurion system will not complete booting, and the message "x-ray system is booting..." remains displayed on the screen.

Issue 5 - Misalignment of marker tool overlay - applicable only to Azurion systems with the marker tool option

When geometry movement exceeds predefined thresholds (e.g., angulation or rotation differences greater than 10°, or a beam-isocenter-to-patient deviation greater than 50 mm), markers are hidden. When the geometry returns within the threshold, markers reappear. However, they may not be restored to their exact original position and can deviate by several millimeters. If the marker tool is used during a clinical procedure to indicate the correct placement of a device, this deviation could lead to incorrect placement of the device.

Issue 6 - Longitudinal position error - applicable only to Azurion systems with poly-g3 frontal stand when requesting a movement of the frontal stand in longitudinal direction, the Azurion system may detect a mismatch between the expected longitudinal (set-) position and the measured (actual) position of the stand. this mismatch is caused by a glitch in the longitudinal position value provided by the position sensing potentiometer.

When the mismatch is detected, the motion power to the frontal stand is automatically cut off. The message "some stand movements are not available" is displayed to the user.