Drug recall
GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational…
FDA recall event 71508 · Class II · GE Healthcare
Key facts
| Event ID | 71508 |
|---|---|
| Recall numbers | Z-1973-2015, Z-1974-2015, Z-1975-2015, Z-1976-2015, Z-1977-2015, Z-1978-2015, Z-1979-2015, Z-1980-2015, Z-1981-2015, Z-1982-2015, Z-1983-2015, Z-1984-2015 and 1 more |
| Recalling firm | GE Healthcare |
| Product type | Devices |
| Products | GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures., GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and…, GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures., GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures., GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. and 8 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and… |
| Initiation date | May 29, 2015 |
| Report date | Jul 8, 2015 |
| Termination date | Oct 28, 2015 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: