Terminated

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).

FDA Recall Z-0705-2012 · Posted 2012-01-11

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeIYN

Date Initiated2012-01-03

Date Terminated2013-01-10

Product Quantity894

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

Firm 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).

Root Cause

Software design

Distribution Pattern

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..

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110943LOGIQ E9GE Healthcare · 2011-07-22

Official Source

View FDA Recall →

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