FDANovember 8, 2023device

Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S...

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

The hazard

A potential for a light system to fall in the operating room.

What to do

FDA enforcement status: Ongoing

Brands named

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Recall history

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

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