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FDAMarch 3, 2020device

Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

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

The hazard

It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.

What to do

FDA enforcement status: Terminated

Brands named

capintec

Recall history

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

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