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U.S. Department of Health and Human Services

Class 2 Device Recall GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1.

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 Class 2 Recall
GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1.
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on January 10, 2013
Recall Number Z-0705-2012
Recall Event ID 60773
Premarket Notification
510(K) Number
K110943 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. 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, vascular and neurosurgical).
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue associated with the data of your LOGIQ E9 system that may impact patient safety. 1 - User may notice an image from a different patient, or an image from the current patient with title information from a different patient. 2  Incorrect measurements/calculations on images, when viewed on the off-line review station. As a re
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, GE Healthcare" sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 20, 2011 to its customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, Contact Information and actions to be taken. The customers were instructed to ensure that all potential users in their facility are made aware of this safety notification and recommended actions and to follow the safety instructions noted in the letter. If you have any questions or concerns, contact your local GEHC service representative at 1-800-321-7937 (USA/Canada).
Quantity in Commerce 894
Distribution Worldwide distribution: USA (nationwide) including states of: AK, AZ, ALR, CA, CO, CT, FL, GA, IL, IN, IA, LA, LME, MD, MA, MI, MN, MS, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TIN, TX, UT, VA, WA, WV, WI, and WY; and countries of: AUSTRALIA, AUSTRIA, BELGIUM CANADA, CHILE, CHINA, CROATIA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PHILIPPINES, PORTUGAL, REPUBLIC OF KOREA, ROMANIA, RUSSIAN FEDERATION,SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN,SWEDEN, SWITZERLAND, TAIWAN, and UNITED KINGDOM..
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = GE HEALTHCARE
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