Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Azurion series (within the limits of the used Operation Recalled by Philips North America Llc Due to Early life failure of the ADUs only occurs...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips North America Llc directly.
Affected Products
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
Quantity: 1 unit
Why Was This Recalled?
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips North America Llc
Philips North America Llc has 301 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report