Azurion 5 X-Ray System Generator May Fail Due to Circuit Short
Philips Azurion 5 X-ray systems with Certeray generators may experience power loss due to a potential short circuit in the power inverter board, potentially delaying or interrupting medical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical imaging equipment with a critical failure mode that could interrupt surgical procedures. The source text indicates no reported injuries or hospitalizations, qualifying this as a risk-of-harm scenario where potential patient impact exists but has not yet materialized.
Plain-English summary
Philips Medical Systems is recalling certain Azurion 5 X-ray systems equipped with Certeray generators due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) located in the PoInt EVR (Power Invertor) component.
If a short circuit occurs, the system's fuses will trip, causing power loss and rendering the equipment non-functional. This could result in delays to or termination of diagnostic, interventional, or minimally invasive surgical procedures that depend on the equipment for image guidance.
The recall affects 27 units distributed worldwide, including installations in eight U.S. states (New York, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington) and numerous other countries. The affected equipment models are 722227 and 722228.
Healthcare facilities with affected systems should contact Philips Medical Systems Nederland B.V. for guidance on inspection, repair, or replacement.
The recalled product
- Product
- Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- power-loss
- system-malfunction
- procedure-interruption
Distribution
Distributed nationwide across the United States.
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