Philips recalled 990 Azurion Systems on December 8, 2025, after nine software issues were identified. The defects may cause loss of X-ray functionality, system restarts, and other operational failures. Healthcare providers must stop using the devices immediately.
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: E-Mail
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The recall involves Philips Azurion Systems R3.0, including models 722229, 722230, 722231, 722232, 722235, 722236, 722233, and 722234. The systems were distributed worldwide, including the US and various countries. These models were sold globally.
Nine software issues may cause loss of X-ray after pedal tap, missing live X-ray on the FlexVision monitor, and continuous system restarts. These malfunctions could compromise patient safety and diagnostic capabilities.
There have been no reported injuries or deaths related to the software malfunctions as of the recall date. The potential for harm remains high due to the critical nature of medical imaging.
Stop using the affected devices immediately. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions. Follow the recall instructions provided by the manufacturer.
For more information, email Philips Medical Systems Nederland B.V. at the contact address provided in the recall notice.
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