GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation 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).

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

On March 23, 2018 GE Healthcare sent letters to their consignees informing them about the recall of LOGIQ 9, LOGIQ E9, Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, and Vivid E95 ultrasound systems which have been installed since April 2015 or which have received a power cord replacement since April 2015. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. Your safety and the safety of your patients is of our utmost concern. Safety Issue The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. This can lead to injuries up to and including cardiac arrhythmia or cardiac arrest. A minor injury has been reported as a result of this issue. Safety Instructions You may continue to use your system. If you need to remove the power cord from the rear of the unit (see picture of location below), before doing so be sure to do the following: 1. Turn the system off 2. Unplug it from the wall If the system end of the power cord (see picture below) is damaged, discontinue use of the system until a replacement cord is provided. If you experience any power issues with your unit, discontinue use of the system and contact GEHC Service. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. Contact Information If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.