GE — Class II medical device recall Z-1188-2013
Terminated recall by GE Healthcare, LLC, reported 2013-05-08, distributed nationwide. Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from
| Recall number | Z-1188-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-07-25 |
| Classified | 2013-04-29 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2014-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CN, CO, CR, CZ, DK, EC, EG, ES, FI, FR, GB, GR, HK, HU, IE, IN, IT, JP, KR, MA, MX, NG, NO, PL, SE, SG, TR, UA |
| Quantity | 166 |
| Reason classes | device malfunction |
| Serial numbers | 00000220652HM2, 00000366477CN8, 00000414273CN3, 00000416117CN0, 00000416195CN6, 00000416200CN4, 00000416201CN2, 00000416202CN0, 00000416220CN2, 00000416231CN9, 00000416267CN3, 00000416268CN1, 00000416269CN9, 00000416284CN8, 00000416286CN3, 00000416295CN4, 00000416301CN0, 00000416307CN7, 00000416332CN5, 00000416333CN3, 00000416353CN1, 00000416363CN0, 00000416371CN3, 00000416372CN1, 00000416388CN7 and 141 more |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1188-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.