Recall Z-2988-2018 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
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
| Date | Mar 22, 2018 |
| Status | Terminated |
| Reason | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. |
| Root cause | Component design/selection |
| Action | On March 23, 2018 GE Healthcare sent letters to their consignees informing them about the recall of LOGIQ 9, LOGIQ E9, Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, and Vivid E95 ultrasound systems which have been installed since April 2015 or which have received a power cord replacement since April 2015. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. Your safety and the safety of your patients is of our utmost concern. Safety Issue The system side of the power cord may break and expose the electrical condu |
| Quantity | 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS) |
| Distribution | Nationwide and Puerto Rico FOREIGN: Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State of Brazil, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Congo, The Democratic Repu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ult Ge Vingmed Ultrasound AS, Mar 4, 2015 |
| K170823 | Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics, Jun 12, 2017 |
| K173341 | Vivid E80, Vivid E90, Vivid E95 GE Medical Systems, Nov 2, 2017 |