Drug recall
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for…
FDA recall event 81165 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 81165 |
|---|---|
| Recall numbers | Z-0588-2019 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury. |
| Initiation date | Sep 14, 2018 |
| Report date | Dec 19, 2018 |
| Termination date | May 29, 2019 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
At a glance
- 1–9 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: