Recall Z-2988-2018— GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
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 3 FDA 510(k) clearances: K173341, K170823, K150087. 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 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
3 on FDA's record- K173341 — Vivid E80, Vivid E90, Vivid E95
- K170823 — Vivid E80, Vivid E90, Vivid E95
- K150087 — Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
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 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).
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.