FDA Device recall Z-1188-2013
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-section…
- FDA Device
- Class II
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class II recall of GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-section… by Ge Healthcare, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1188-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-07-25 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
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.
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
Identifiers
| code_info | Serial Number 00000416307CN7 00000416534CN6 00000418451CN1 00000416467CN9 00000414273CN3 00000416594CN0 00000416…Serial Number 00000416307CN7 00000416534CN6 00000418451CN1 00000416467CN9 00000414273CN3 00000416594CN0 00000416589CN0 00000416532CN0 00000417617CN8 00000416889CN4 00000416685CN6 00000418151CN7 00000416332CN5 00000416591CN6 00000416468CN7 00000416333CN3 00000419445CN2 00000416269CN9 00000416815CN9 00000416117CN0 00000416524CN7 00000416267CN3 00000419240CN7 00000416646CN8 00000417864CN6 00000416195CN6 00000419505CN3 00000418001CN4 00000416816CN7 00000416551CN0 00000416201CN2 00000417625CN1 00000417650CN9 00000416220CN2 00000419411CN4 00000416390CN3 00000418913CN0 00000416737CN5 00000416738CN3 00000416777CN1 00000416363CN0 00000416888CN6 00000416590CN8 00000417177CN3 00000419041CN9 00000416850CN6 00000416627CN8 00000417275CN5 00000417709CN3 00000417133CN6 00000419446CN0 00000419375CN1 00000418807CN4 00000418035CN2 00000418238CN2 00000418843CN9 00000417786CN1 00000419393CN4 00000417695CN4 00000419507CN9 00000419078CN1 000004192 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1188-2013%22
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