FDANovember 12, 2021device

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

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

The hazard

(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

00884838085367008848380992720088483809923400884838099203008848380992650088483809925800884838085251

Recall history

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

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