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FDAJune 24, 2019device

Ingenuity Core Model # 728321, computed tomography x-ray system

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

The hazard

In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

What to do

FDA enforcement status: Terminated

Brands named

philips medical systems clevelandphilipsphilips medical

UPCs

310050310121310050310125

Recall history

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

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