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FDAApril 12, 2023device

Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

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

The hazard

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

What to do

FDA enforcement status: Ongoing

Brands named

philips headquarters cambridgephilipsphilips headquarters

UPCs

00884838105508

Recall history

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

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Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144 — Recall Details · AllClear