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FDADecember 19, 2022device

GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW...

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

The hazard

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

What to do

FDA enforcement status: Ongoing

Brands named

ge medical systems israel functional imaging

UPCs

0084068214077500840682140751

Recall history

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

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