Recall Z-2983-2018 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
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; Transesoph
| 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
| K082185 | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 Ge Medical Systems Ultrasound and Primary Care Dia, Aug 15, 2008 |
| K092271 | GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 GE Healthcare, Nov 17, 2009 |
| K110943 | LOGIQ E9 GE Healthcare, Jul 22, 2011 |
| K123564 | LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE Healthcare, Dec 18, 2012 |
| K142160 | LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE Healthcare, Oct 10, 2014 |