Recall Z-2985-2018— GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Name: FDA recall Z-2985-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-22

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, initiated 2018-03-22, terminated 2021-08-24. It names one FDA 510(k) clearance: K131514. 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). Reason: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock..

Recalling firm: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Classification: Class II
Status: Terminated
Initiated: 2018-03-22
Terminated: 2021-08-24
Firm location: Milwaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K131514 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMGe Vingmed Ultrasound AS·cleared 2013-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.