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FDAFebruary 22, 2021device

Incisive CT Computed Tomography X-ray System Model: 728143

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

The hazard

Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

0088483805984900884838085015

Recall history

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

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