The Recall Desk
SevereFDA (Devices)·Z-1623-2015·Announced 2015-05-27

GE Healthcare Recalls CT Scanners Due to Over-Torqued Bolts

GE Healthcare is recalling four CT scanners because over-torqued bolts could cause a component to detach, posing a risk of serious bodily injury.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as Severe because the source text explicitly states that the defect could result in serious bodily injury if the component is expelled, which aligns with the rubric criteria for significant injury reports or high-risk structural defects.

Plain-English summary

GE Healthcare is recalling four units of the CT LightSpeed 16 and Discovery ST Pet/CT DST scanners (Catalogue # 2339985). The recall was initiated because three bolts that secure a power supply to the rotating side of the gantry were found to be over-torqued on certain units.

The affected devices were distributed to the states of Minnesota, Florida, and Texas. The specific units are identified by the following System IDs: 00000331100CN8, 00000345975CN7, 00000337343CN8, and 00000344962CN6.

In the unlikely event that the component becomes loose on the CT gantry during operation, it could be expelled, resulting in serious bodily injury. No incidents or injuries have been reported as a result of this defect. Healthcare facilities should contact GE Healthcare to arrange for the necessary corrective actions.

The recalled product

Product
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.
Manufacturer
GE Healthcare
Affected units
4

Distribution

Distributed in 3 states: