GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to pr
FDA device recall Z-1188-2013 · posted 2013-04-29 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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 countrie
- Date initiated
- 2011-07-25
- Date posted
- 2013-04-29
- Date terminated
- 2014-02-04
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIMA PET/CT 560 (K081496) | Ge Medical Systems, LLC | 2008-06-12 |
| GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) (K081105) | GE Healthcare | 2008-05-09 |
| LIGHTSPEED 7.0 CT SCANNER SYSTEM (K040372) | Ge Medical Systems, LLC | 2004-03-01 |
| LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM (K030420) | GE Medical Systems | 2003-03-10 |
| LIGHTSPEED 4.0 CT SCANNER SYSTEM (K013561) | GE Medical Systems | 2001-11-08 |