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FDAMarch 29, 2024device

The Oncology Essentials Package of the Spectral CT imaging system.

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

The hazard

Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

00884838101111

Recall history

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

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The Oncology Essentials Package of the Spectral CT imaging system. — Recall Details · AllClear