GE Healthcare recalls CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner util…

Recall date

April 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1623-2015

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

Distributed to the states of MN, FL & TX.

Why it was recalled

GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely event that the component becomes loose on the CT gantry during operation, it could result in serious bodily injury if the component were expelled. There were no incidents or injuries reported as a res

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.