CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utili

FDA device recall Z-1623-2015 · posted 2015-05-15 · Terminated

Recall details

Recalling firm

GE Healthcare

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

Action taken

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 25461 dated April 22, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter stated that customers can continue to use their device. If the error occurs, then stop using the system and call a service representative to bring the system back into proper operation. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. UPDATED: Consignees were sent on 5/14/2015 a second GE Healthcare "Urgent Medical Device Correction" letter dated May 14th, 2015. The letter was to incorporate and additional unit being recalled.

Root cause

Process design

Status

Terminated

Product code

JAK

Quantity affected

4 USA

Distribution

Distributed to the states of MN, FL & TX.

Date initiated

2015-04-22

Date posted

2015-05-15

Date terminated

2015-07-15

Location

Waukesha, WI

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