Philips recalled 228 Azurion systems on December 12, 2025, due to software issues that may cause loss of X-ray functionality. The problems can result in incorrect image content and motorized movement failure. Affected devices were distributed internationally across multiple countries.
Philips has identified two (2) software issues affecting device 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 remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
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 involves Philips Azurion systems with software version R3.1. Affected model numbers include 722221, 722222, 722223, 722224, 722225, 722226, and 722227. The devices were distributed internationally.
Philips identified two software issues. One issue causes the system to stay in continuous restart mode. The second issue involves a longitudinal position error, particularly in systems with the Poly-G3 frontal stand.
No specific incidents of injuries or deaths have been reported. However, the potential loss of imaging functionality poses significant risks in medical settings.
Stop using the Azurion system immediately. Follow any recall instructions provided by Philips. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions.
For assistance, call Philips Medical Systems at their official contact number or visit their website. Additional information is available at the FDA's recall page.
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