Class 2 Device Recall GE LOGIQ E10 Ultrasound System

• Date Initiated by Firm: September 14, 2018
• Create Date: December 07, 2018
• Recall Status: Terminated on May 29, 2019
• Recall Number: Z-0588-2019
• Recall Event ID: 81165
• 510(K)Number: K173555
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: 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; Transvaginal; Transesophageal and Intraoperative (vascular).
• Code Information: Serial numbers 500055US7, 500103US7, 500022US7, 500059US7, 00066US7, 500083US7, 500057US7, 500130US7, 500114US7, 500105US7, 500111US7, 500039US7,500132US7, 500064US7, 500128US7, 500131US7, 500063US7, 500062US7, 500104US7, 500139US7, 500126US7, 500127US7, 500125US7, 500138US7, 500140US7, 500095US7, 500099US7, 500100US7, 500102US7, 500097US7, 500060US7, 500020US7, 500002US7, 500019US7, 500093US7, 500003US7, 500004US7,500005US7, 500065US7, 500072US7, 500058US7, 500049US7, 500050US7, 500047US7, 500035US7, 500021US7, 500023US7, 500024US7, 500025US7, 500026US7, 500007US7, 500008US7, 500009US7, 500010US7, 500013US7, 500014US7, 500016US7, 500017US7, 500012US7, 500029US7, 500043US7, 500061US7, 500006US7, 500015US7, 500085US7, 500080US7, 500042US7, 500070US7, 500030US7, 500122US7, 500082US7, 500135US7, 500121US7, 500086US7, 500027US7, 500048US7, 500053US7, 500054US7, 500056US7, 500116US7, 500038US7, 500045US7, 500036US7, 500051US7, 500073US7, 500076US7, 500079US7, 500084US7, 500091US7, 500034US7, 500077US7, 500133US7, 500087US7, 500134US7, 500074US7, 500068US7, 500037US7, 500018US7, 500069US7, 500067US7, 500071US7, 500044US7, and 500090US7.
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: Mr. Ben Fox; 414-721-4013
• Manufacturer Reason for Recall: There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
• FDA Determined 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 have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYN and Original Applicant = GE Healthcare