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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, LOGIQ e Ultrasound System.

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 Class 2 Device Recall GE Healthcare, LOGIQ e Ultrasound System. see related information
Date Posted August 01, 2013
Recall Status1 Terminated on September 15, 2014
Recall Number Z-1849-2013
Recall Event ID 65759
510(K)Number K113690 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product GE Healthcare, LOGIQ e Ultrasound System.

The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
FDA Determined
Cause 2
Software design
Action Starting on November 9, 2012, GE Healthcare, will plan to update the software on all of the affected GE LOGIQ e Ultrasound systems that were distributed at no cost to the customer. As an effectiveness check, we will track all service requests for the field action to completion. These service requests will record the repair of the affected units. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures. No Customer letter was sent. Further questions please call (262) 513-4122.
Quantity in Commerce 588
Distribution Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL , IA, MD, MA, MI, MS, MO, NJ, NM, NY, NC, OH, PA, RI, SC, TN,TX, UT,VT, VA and WI., and the countries of ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, INDIA, ITALY, JAPAN, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND and UNITED EMIRATES.
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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