GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a… — Class II medical device recall Z-2989-2018
Terminated recall by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, reported 2018-09-12, distributed nationwide. The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
| Recall number | Z-2989-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, Milwaukee, WI, United States |
| Recall initiated | 2018-03-22 |
| Classified | 2018-09-06 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2021-08-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JM, JO, JP, KE, KR, KW, LB, LU, LV, MA, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Reason classes | device malfunction |
Product
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 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; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Reason for recall
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
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-2989-2018. 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.