Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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 |
| 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. |
| 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 DENMARK ECUADOR EGYPT FINLAND FRANCE GREECE HONG KONG HUNGARY INDIA IRELAND ITALY JAPAN KOREA, REPUBLIC … |
| Initiated | 2011-07-25 |
| Classified | 2013-04-29 |
| Terminated | 2014-02-04 |
| Recall number | Z-1188-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-1188-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64889/
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