GE Healthcare — Class II medical device recall Z-1833-2013
Terminated recall by GE Healthcare, LLC, reported 2013-08-07, distributed in AK, AR, AZ, CA, CO, CT, DE, FL…. GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message
| Recall number | Z-1833-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-07-13 |
| Classified | 2013-07-31 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2014-11-10 |
| Distributed | AK, AR, AZ, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NC, NE, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, WI |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CN, CO, DE, DK, DZ, EG, ES, FI, FR, GB, IL, IN, IQ, IT, JO, JP, KR, NL, NO, PL, RO, SA, SE, SK, TH, TR, TW, VE, ZA |
| Quantity | 375 |
| Serial numbers | D00101, D00688, D00716, D00853, D01077, D03104, D03377, D03382, D03958, D04334, D04391, D04446, D05257, D05445, D10516, D11004, D11398, D11419, D11463, D13350, D13472, D13829, D15189, D15232, D15425 and 349 more |
Product
GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).
Reason for recall
GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system.
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-1833-2013. 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.