PlainRecalls
FDA Devices Moderate Class II Terminated

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).

Reported: December 19, 2018 Initiated: September 14, 2018 #Z-0588-2019

Product Description

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).

Reason for Recall

There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
103 devices(64 US; 39 OUS)
Distribution
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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).. Recalled by GE Healthcare, LLC. Units affected: 103 devices(64 US; 39 OUS).
Why was this product recalled? ▼
There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0588-2019.

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