FDAJanuary 2, 2024device

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;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

philips medical systems nederland b vphilipsphilips medical

UPCs

0088483805929000884838064775008848380853500088483805920700884838085367008848380852510088483809924100884838059191008848380592210088483808526800884838086777

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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