Recall Z-0588-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvagi
| Date | Sep 14, 2018 |
| Status | Terminated |
| Reason | There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury. |
| Root cause | Process change control |
| Action | The recalling firm, GE Healthcare, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 9/14/2018 via traceable means to each of their customer locations. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Do not use a TEE probe (GE model 6Tc-RS) from another device on the LOGIQ E10 system until your LOGIQ E10 is corrected. You may scan normally with any other probes. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you h |
| Quantity | 103 devices(64 US; 39 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AZ, IL, MA, ME, MN, MT, PA, TX, and WA and countries of: Foreign distribution was made to Austria, Denmark, Finland, and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173555 | LOGIQ E10 GE Healthcare, Dec 20, 2017 |