GE Healthcare: Medical Device Recall in 2015 - (Recall #: Z-1623-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 22, 2015

Date Posted: May 27, 2015

Recall Number: Z-1623-2015

Event ID: 71167

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

Status: Terminated

Product Quantity: 4 USA

Code Information:

Mfg Lot or Serial # System ID 00000331100CN8 904223CT 00000345975CN7 409838LS16 00000337343CN8 512OCCT 00000344962CN6 INSIGHTPCT1356

Distribution Pattern:

Distributed to the states of MN, FL & TX.

Voluntary or Mandated:

Voluntary: Firm initiated