FDASeptember 12, 2025device

Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

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

The hazard

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

What to do

FDA enforcement status: Ongoing

Brands named

ge medical systems israel functional imaging

Recall history

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

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