Veradius Unity and BV Pulsera Mobile C-Arm System-9in. and 12in. Versions

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

Air bubbles may develop in the monoblock oil when there is a prolonged period between manufacture and installation, for example due to storage, transportation, or other pre-installation holding time. During a clinical procedure, when the user activates X-ray imaging, if an air bubble becomes trapped in the high-voltage area of the monoblock, there could be an internal electrical discharge (flashover) resulting in X-rays not being generated and consequently no image being displayed on the examination monitor. When this situation occurs, the system displays an error message indicating that the X-ray generator is not available. In some cases, restarting the system (which takes approximately 5 minutes) may restore X-ray generation. Philips' investigation indicates that this issue may occur during the early period of system use following a prolonged period between manufacture and installation. Based on the investigation, potentially affected systems have been identified as those for which more than 300 days elapsed between manufacture and installation and fewer than 250 days have elapsed since installation with continued system use, the monoblock oil temperature increases, allowing storage-related air bubbles to gradually dissipate over time.