GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
FDA Recall Z-1188-2013 · Posted 2013-04-29
Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2011-07-25
Date Terminated2014-02-04
Product Quantity166
Reason for Recall
Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspe
Firm Action
No consignee letter was sent out. At customer site Field Engineer replaced heat exchanger, the tube and the pump. Field Engineer also verified torque on all bolts. Field action was initiated on 7/25/2011 and has been completed as of 3/29/2013.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CO, CT, FL,GA, IL, IN, KY, MA, MI, MS,MO, NH, NJ, NM, NY, NC, OK, OR, PA, SC, SD, TX, UT, VA, WA, and WI and the countries of ALBANIA ARGENTINA AUSTRALIA BELGIUM BRAZIL CANADA CHINA COLOMBIA COSTA RICA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GREECE HONG KONG HUNGARY INDIA IRELAND ITALY JAPAN KOREA, REPUBLIC OF MEXICO MOROCCO NIGERIA NORWAY POLAND RUSSIAN FEDERATION SINGAPORE SPAIN SWEDEN SWITZERLAND TURKEY UKRAINE UNITED KINGDOM.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K081496OPTIMA PET/CT 560Ge Medical Systems, LLC · 2008-06-12K081105GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)GE Healthcare · 2008-05-09K040372LIGHTSPEED 7.0 CT SCANNER SYSTEMGe Medical Systems, LLC · 2004-03-01K030420LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEMGE Medical Systems · 2003-03-10K013561LIGHTSPEED 4.0 CT SCANNER SYSTEMGE Medical Systems · 2001-11-08
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.