GE Healthcare — Class II medical device recall Z-1849-2013
Terminated recall by GE Healthcare, LLC, reported 2013-08-07, distributed nationwide. GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patien
| Recall number | Z-1849-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-11-09 |
| Classified | 2013-08-01 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2014-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, DE, DK, ES, FI, FR, GB, HK, IN, IT, JP, NL, NO, NZ, PL, RU, SA, SE, SG, ZA |
| Quantity | 588 |
| Serial numbers | 216340WX0, 216341WX8, 223130WX6, 223131WX4, 223132WX2, 223133WX0, 223134WX8, 223135WX5, 223136WX3, 223137WX1, 224634WX6, 224635WX3, 224636WX1, 224637WX9, 224638WX7, 224639WX5, 224640WX3, 224641WX1, 224642WX9, 224643WX7, 224644WX5, 224645WX2, 224786WX4, 224787WX2, 224788WX0 and 475 more |
Product
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
Reason for recall
GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
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-1849-2013. 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.