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FDADecember 19, 2022device

GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25...

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

53762047020

Recall history

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

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GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25... — Recall Details · AllClear