FDA-Device2018-12-19Class II
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (vascular).
GE Healthcare, LLC
Hazard
There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
Sold states
Worldwide Distribution: US (nationwide) to states of: AZ, IL, MA, ME, MN, MT, PA, TX, and WA and countries of: Foreign distribution was made to Austria, Denmark, Finland, and Norway.
Affected count
103 devices(64 US; 39 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (vascular).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0588-2019Don't want to check this manually?
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