medical Class II Updated 2018-09-12

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Vivid E9 ultrasound system Product Usage: GE Vivi

Recalled Product

GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, Testes, thyroid; Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, Thoracic, & vascular)


Hazard / Issue

The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Each consignee have one serial numbers assigned
View official government recall

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