Philips Azurion X-ray System: Potential Loss of Imaging Functionality
The Philips Azurion Interventional Fluoroscopic X-ray System may lose imaging functionality or experience longer restart times. The FDA is recalling approximately 3,011 units of this device worldwide.
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 recall with no reported illnesses or injuries. The potential loss of imaging functionality and extended restart times could interrupt diagnostic and interventional procedures, but no actual harm has been documented. Per the rubric, recalls involving risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
The FDA is recalling the Philips Azurion Interventional Fluoroscopic X-ray System (models 722063, 722064, 722067, 722068, 722078, and 722079) with software versions R1.0, R1.1, or R1.2. This diagnostic imaging device is intended to guide vascular, non-vascular, cardiovascular, and neurological procedures.
The recalled systems may experience a potential loss of X-ray imaging functionality and/or require longer times to complete a cold restart.
Approximately 3,011 units have been distributed worldwide, including in the United States and numerous international locations. The device manufacturer is Philips Medical Systems Nederland B.V.
The recalled product
- Product
- Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, car
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- imaging-loss
- cold-restart-delay
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 (8)
- Model /UDI-DI: (1) 722063 (01)00884838085275(21)
- (2) 722064 (01)00884838085282(21)
- (3) 722067 (01)00884838085350(21)
- (4) 722068 (01)00884838085367(21)
- (5) 722078 (01)00884838085251(21)
- (6) 722079 (01)00884838085268(21). Software Version Number: R1.0
- R1.1
- R1.2
Distribution
Distributed nationwide across the United States.
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