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FDADecember 10, 2020device

GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

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

The hazard

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

What to do

FDA enforcement status: Ongoing

Brands named

ge healthcare

Recall history

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

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