Philips Azurion 3 Surgical Imaging System Recalled for Power Failure Risk
Philips is recalling 14 units of its Azurion 3 surgical imaging system due to a potential short circuit in the power inverter. The defect could cause the device to lose power and fail during 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: FDA Class II medical device with potential for power loss and system malfunction during critical surgical procedures. No illnesses or injuries have been reported; this qualifies as a risk-of-harm product where injury has not yet been reported, per rubric criterion for Score 3.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 14 units of the Azurion 3 with Certeray generator (three models: 722221, 722222, and 722280), which is used to provide image guidance during diagnostic, interventional, and minimally invasive surgical procedures.
The recall is due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) of the Power Invertor component. If a short circuit occurs, the system's fuses will trip, cutting power to the device and causing it to become non-functional.
When the device loses power, it cannot provide the image guidance needed for surgery, potentially causing delays or cancellation of surgical procedures.
The affected units have been distributed worldwide, including in the United States (New York, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, and Washington) and numerous international locations. Healthcare facilities that have received these devices should contact Philips Medical Systems Nederland B.V. for instructions regarding remediation, repair, or replacement.
The recalled product
- Product
- Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- short-circuit
- power-failure
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- OUS: (1) Model: 722221 SN: 66 (01)00884838099203(21)66
- SN: 91 (01)00884838099203(21)91
- SN: 104 (01)00884838099258(21)104
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03