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Terminated

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.

FDA Recall Z-1849-2013 · Posted 2013-08-01

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIYN
Date Initiated2012-11-09
Date Terminated2014-09-15
Product Quantity588

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113690GE LOGIQ I, LOGIQ E AND VIVID EGE Healthcare · 2011-12-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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