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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Philips Azurion Systems are advanced medical imaging devices used in healthcare settings for various diagnostic and therapeutic procedures. They are designed to enhance imaging quality and support patient care.
The identified software issues can lead to critical system failures which may disrupt medical procedures and affect patient safety.
This recall is not part of a broader industry pattern.
The recall may disrupt healthcare services where these devices are employed, posing risks to patient safety and care continuity.
Model numbers and software versions are typically found on the device's label or in the user manual.
Expect potential delays in processing refunds or replacements as Philips addresses the recall.
Keep records of all communications regarding the recall, including dates, responses, and any relevant documentation.
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.
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