Philips Azurion Interventional X-ray Systems framegrabber card may fail to display images
The framegrabber card in Philips Azurion interventional X-ray systems may fail to display diagnostic images properly, potentially delaying 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 FDA Class II medical device recall involves a diagnostic imaging system component that may malfunction. While no illnesses or injuries have been reported, the potential failure of the framegrabber card could impair diagnostic imaging and delay procedures, constituting a risk-of-harm situation per rubric criteria.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Disk Bay component of the personal computer in specific Azurion interventional fluoroscopic X-ray systems. The affected models are Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078 and 722223), and Azurion 7 M20 (722079). Approximately 1,993 systems were distributed in the United States, with an additional 2,662 units distributed worldwide.
The framegrabber card in the PC's Disk Bay may not perform as intended. When the device malfunctions, the monitor may display no viewport images, show one or more viewports with no image, distorted images, or frozen images. Switching between viewport displays may not be possible. These failures could result in delays to clinical procedures and may impact diagnostic capability.
Facilities with affected systems should contact Philips Medical Systems for instructions on device service or replacement. Healthcare providers should verify their facility's equipment serial numbers against the recall notice to determine if their systems are affected.
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: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- framegrabber-malfunction
- display-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 (8)
- Azurion 7 B12 722067 - UDI-DI 00884838059290
- 00884838064775
- Azurion 7 B20 722068 - UDI-DI 00884838059207
- 722223 - UDI-DI 00884838099241 Serial Number 206
- Azurion 7 M20 722079 - UDI-DI 00884838059191
- 00884838059221
- 00884838059290
- 00884838085268
Distribution
Distributed nationwide across the United States.
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