Recall Z-1623-2015— GE Healthcare

Name: FDA recall Z-1623-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-22

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-04-22, terminated 2015-07-15. It names one FDA 510(k) clearance: K013561. 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.. Reason: 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.

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Terminated: 2015-07-15
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K013561 — LIGHTSPEED 4.0 CT SCANNER SYSTEMGE Medical Systems·cleared 2001-11-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.