Azurion 7 Medical Imaging System May Lose Power During Procedures
Philips Azurion 7 imaging systems may experience power loss due to a potential short circuit in the power inverter, risking delays or termination of diagnostic and surgical 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 medical device used in surgical and interventional procedures. The potential short circuit hazard could cause system failure and procedure interruption, representing a risk-of-harm product in a critical clinical setting. Although no injuries have been reported, the hazard is real and could occur during active procedures.
Plain-English summary
Philips Medical Systems has recalled Azurion 7 imaging systems with Certeray generators used for image guidance in diagnostic, interventional, and minimally invasive surgery procedures. The devices may experience power loss due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) within the Power Invertor (PoInt EVR). If a short circuit occurs, the fuses will trip and the system will lose power, making it non-functional.
This failure could result in delays to ongoing procedures or complete termination of procedures. The recall affects 10 units in the U.S. (distributed to NY, PA, PR, TN, TX, VA, and WA) and 124 units outside the U.S., distributed across multiple countries.
Healthcare facilities using affected Azurion 7 systems should contact Philips Medical Systems to verify whether their devices are included in this recall using the provided serial numbers and model information. Facilities should review their current procedures and consider backup imaging systems while working with the manufacturer to remediate or replace affected equipment.
The recalled product
- Product
- 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
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- electrical-short-circuit
- power-failure
- procedure-interruption
Distribution
Distributed nationwide across the United States.
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