Drug recall
GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for…
FDA recall event 80928 · Class II · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Key facts
| Event ID | 80928 |
|---|---|
| Recall numbers | Z-2983-2018, Z-2984-2018, Z-2985-2018, Z-2986-2018, Z-2987-2018, Z-2988-2018, Z-2989-2018, Z-2990-2018 |
| Recalling firm | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL |
| Product type | Devices |
| Products | GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid)…, GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid)…, GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified…, GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified…, GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction… and 3 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. |
| Initiation date | Mar 22, 2018 |
| Report date | Sep 12, 2018 |
| Termination date | Aug 24, 2021 |
| City | Milwaukee |
| State | WI |
| Country | United States |
| FEI number | 3005860720 |
At a glance
- 1–9 Products in this recall
- 1–9 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: