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FDADecember 19, 2022device

GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 870 DR 5/8 inch NM GANTRY, j)...

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

53762047060153762047061153762047060

Recall history

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

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