Vivid E95/E90/E80 — Class II medical device recall Z-1779-2017
Terminated recall by GE Healthcare, LLC, reported 2017-04-19. GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by
| Recall number | Z-1779-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2017-03-10 |
| Classified | 2017-04-11 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2018-03-12 |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, NL, NO, NZ, PA, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, UY, VN, ZA |
Product
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Reason for recall
GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.
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-1779-2017. 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.