Recall Z-1188-2013 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
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.
| Date | Apr 29, 2013 (initiated Jul 25, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Process control |
| 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. |
| Quantity | 166 |
| Distribution | 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 DENM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013561 | LIGHTSPEED 4.0 CT SCANNER SYSTEM GE Medical Systems, Nov 8, 2001 |
| K030420 | LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM GE Medical Systems, Mar 10, 2003 |
| K040372 | LIGHTSPEED 7.0 CT SCANNER SYSTEM Ge Medical Systems, LLC, Mar 1, 2004 |
| K081105 | GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) GE Healthcare, May 9, 2008 |
| K081496 | OPTIMA PET/CT 560 Ge Medical Systems, LLC, Jun 12, 2008 |