FDA (Devices) recall action 80928

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalled 8 products on 2018-09-12

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2018-09-12
Critical: 0
Units: —

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–8 of 8

SevereFDA (Devices)··2018-09-12
GE Vivid E7 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling Vivid E7 ultrasound systems because the power cord may break and expose electrical conductors, creating a risk of electric shock.
Product
GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (
Category
Distribution
1 state
HighFDA (Devices)··2018-09-12
GE LOGIQ 9 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 LOGIQ 9 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.
Product
GE LOGIQ 9 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
Category
Distribution
1 state
HighFDA (Devices)··2018-09-12
GE Vivid E90 Ultrasound System Recalled for Electrical Shock Risk
GE Medical Systems is recalling Vivid E90 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of shock.
Product
GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis o
Category
Distribution
1 state
HighFDA (Devices)··2018-09-12
GE Vivid E95 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 Vivid E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.
Product
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 pedia
Category
Distribution
1 state
HighFDA (Devices)··2018-09-12
GE LOGIQ E9 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 LOGIQ E9 ultrasound systems because the power cord side may break, exposing electrical conductors and creating a risk of electric shock.
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 V
Category
Distribution
1 state
HighFDA (Devices)··2018-09-12
GE Vivid 7 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 Vivid 7 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.
Product
GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (i
Category
Distribution
1 state
HighFDA (Devices)··2018-09-12
GE Vivid E80 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling Vivid E80, E90, and E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.
Product
GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetr
Category
Distribution
1 state
HighFDA (Devices)··2018-09-12
GE Vivid E9 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 Vivid E9 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of electric shock.
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 (in
Category
Distribution
1 state