FDAMay 1, 2021device

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

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

The hazard

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

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Recall history

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

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