Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Due to Generator may fail due to a potential short...
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 MEDICAL SYSTEMS NEDERLAND B.V. directly.
Affected Products
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
Quantity: 10 units US; 124 units OUS
Why Was This Recalled?
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report