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U.S. Department of Health and Human Services

Class 2 Device Recall CT LightSpeed 16 and Discovery ST Pet/CT DST

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  Class 2 Device Recall CT LightSpeed 16 and Discovery ST Pet/CT DST see related information
Date Initiated by Firm April 22, 2015
Date Posted May 15, 2015
Recall Status1 Terminated 3 on July 15, 2015
Recall Number Z-1623-2015
Recall Event ID 71167
510(K)Number K013561  
Product Classification System, x-ray, tomography, computed - Product Code JAK
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.
Code Information Mfg Lot or Serial # System ID 00000331100CN8 904223CT 00000345975CN7 409838LS16 00000337343CN8 512OCCT  00000344962CN6 INSIGHTPCT1356 
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer 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
FDA Determined
Cause 2		 Process design
Action 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.
Quantity in Commerce 4 USA
Distribution Distributed to the states of MN, FL & TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE MEDICAL SYSTEMS
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