Philips Azurion X-Ray Systems may lock up during simultaneous button presses
Philips Azurion Interventional X-Ray Systems (software 2.1.x) may experience imaging lock-up when operators simultaneously press both the APC and Float Tabletop buttons.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II recall affects a medical imaging device used in interventional procedures. While no injuries have been reported in the source, the software defect creates a risk-of-harm situation by causing complete device lock-up and loss of imaging capability during patient procedures.
Plain-English summary
The recall involves Philips Azurion Interventional Fluoroscopic X-Ray Systems running software version 2.1.x, affecting multiple models including the Azurion 3, 5, and 7 series.
A software defect causes the device to lock up when operators simultaneously press and release both the APC (accept) button and the Float Tabletop (panning) button. When this interaction occurs, the system's geometry stops responding to movement requests and X-ray imaging becomes unavailable.
Approximately 428 units have been distributed within the United States, with 581 additional units distributed internationally. Healthcare facilities using these systems should contact Philips North America for updated software or guidance regarding this issue.
The recalled product
- Product
- Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7…
- Manufacturer
- Philips North America Llc
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 (1)
- Software version 2.1.x Serial Number
Distribution
Distributed nationwide across the United States.
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