GE LOGIQ E9 ultrasound system Product Usage: The device is intended… — Class II medical device recall Z-2983-2018
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-2983-2018 |
|---|---|
| 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 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); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and 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-2983-2018. 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.