Recall Z-2984-2018— 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 one FDA 510(k) clearance: K061129. 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 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
1 on FDA's recordK-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 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 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.