Philips recalled 10,466 Azurion Systems on December 12, 2025, due to six software issues that can cause system failures. Users must stop using the devices immediately. The recall affects models sold worldwide, including in the U.S.
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional 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: Letter
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The recall includes Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Specific models affected are Azurion 3 M12, M15; Azurion 5 M12, M20; and Azurion 7 B12, B20, M12, M20.
Six identified software issues may lead to system failures. These include continuous restarts and misalignments that could affect patient safety.
There have been no reported injuries or deaths linked to this software issue. The potential risks remain high given the nature of the device.
Stop using the affected devices immediately. Follow the recall instructions from Philips Medical Systems. Contact your healthcare provider for further guidance.
For more information, contact Philips Medical Systems Nederland B.V. at the provided recall link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1091-2026.
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