FDA Device recall Z-2986-2018
GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardia…
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardia… by Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll, citing the system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2986-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-22 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll |
| Distribution | US |
Product
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 of a qualified physician for ultrasound imaging and analysis of fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoracic, & vascular).
Reason
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Identifiers
| code_info | Each consignee have one serial numbers assigned |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2986-2018%22
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