FDASeptember 24, 2021device

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 B12, Azurion 7 B20...

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

The hazard

When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

008848380992580088483809924100884838085251008848380852680088483809920300884838099272008848380992340088483809921000884838085367008848380852820088483808527500884838099265

Recall history

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

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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 B12, Azurion 7 B20... — Recall Details · AllClear