Philips Azurion X-ray Systems Disk Bay May Fail and Prevent Imaging
The disk bay component in certain Philips Azurion x-ray systems may fail, potentially preventing diagnostic imaging and delaying procedures. Affected units have been distributed 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 a Class II device recall where the disk bay component may fail, potentially preventing diagnostic imaging procedures and delaying patient care. No injuries or illnesses have been reported, but the functional failure represents a risk to patient outcomes through diagnostic delay, meeting the criteria for High severity.
Plain-English summary
Philips is recalling certain Azurion interventional fluoroscopic x-ray systems due to a potential failure of the disk bay component in the system's PC (personal computer). The disk bay may not perform as intended.
If the disk bay fails, the system may stop functioning, preventing diagnostic imaging and delaying patient procedures.
Approximately 13,133 units have been distributed worldwide, including 3,408 units within the United States. The affected systems span multiple model numbers and serial numbers as documented in FDA recall Z-1152-2024.
The recalled product
- Product
- Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- device-malfunction
- diagnostic-failure
- procedure-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 (17)
- 722221 - UDI-DI 00884838099203 Serial Numbers 19 3 6 7 9
- 722222 - UDI-DI 00884838099210 Serial Numbers 12 15 17 19 23
- Azurion 7 B12 722067 - UDI-DI 00884838059290
- 00884838064775
- 722225 - UDI-DI 00884838099265 Serial Numbers 28 29 37 41 53 72
- Azurion 7 B20 722068 - UDI-DI 00884838059207
- 00884838085367
- Azurion 7 M20 722079 - UDI-DI 00884838059191
- 00884838059207
- 00884838059221
- 00884838059290
- 00884838085268
- 00884838086777
- 00884838101883
- 722224 - UDI-DI 00884838059184
- 00884838059191
- 00884838099258
Distribution
Distributed nationwide across the United States.
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