GE Vivid E9 Ultrasound System — Class II medical device recall Z-1488-2014
Terminated recall by GE Healthcare, LLC, reported 2014-04-30, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance setting
| Recall number | Z-1488-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-03-27 |
| Classified | 2014-04-22 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2015-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CO, CZ, DE, DK, ES, FI, FR, GB, IE, IN, IT, JP, KR, NO, PL, PT, RU, SE, SG, TW, ZA |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 83037001070513 |
Product
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.
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-1488-2014. 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.