FDAJune 8, 2021device

728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

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

The hazard

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

Recall history

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

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728327 Ingenuity CT Upgrades-Computed Tomography X-ray system — Recall Details · AllClear