PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 27, 2015 Initiated: April 22, 2015 #Z-1623-2015

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
GE Healthcare
Units Affected
4 USA
Distribution
Distributed to the states of MN, FL & TX.
Location
Waukesha, WI

Frequently Asked Questions

What product 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.. Recalled by GE Healthcare. Units affected: 4 USA.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on May 27, 2015. Severity: Moderate. Recall number: Z-1623-2015.