Recall Z-2983-2018— GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Name: FDA recall Z-2983-2018
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 5 FDA 510(k) clearances: K142160, K123564, K110943 and 2 more. Product: GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and 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

5 on FDA's record

K142160 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEMGE Healthcare·cleared 2014-10-10
K123564 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEMGE Healthcare·cleared 2012-12-18
K110943 — LOGIQ E9GE Healthcare·cleared 2011-07-22
K092271 — GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4GE Healthcare·cleared 2009-11-17
K082185 — GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia·cleared 2008-08-15

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 LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and 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.