FDA recall Z-1145-2024

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; Azurion 7 M20 722079;

Reason for recall

Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-01-02

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Best, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1145-2024