Terminated

GE Healthcare, LOGIQ S8 Ultrasound System 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 and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

FDA Recall Z-1944-2013 · Posted 2013-08-09

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeIYN

Date Initiated2012-08-13

Date Terminated2014-09-15

Product Quantity755

Reason for Recall

GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measur

Firm Action

GE initiated a field action on 8/13/12. GE plans to update the software on all of the affected GE LOGIQ S8 Ultrasound systems that were distributed, at no cost to the customer. Should you have any questions or require additional information, please contact RA Leader, US Region by telephone at 262-548-2089 or email [email protected].

Root Cause

Software design

Distribution Pattern

Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IL, IN, IA, LA, MA, MI, MS, MO, MT, NE, NV, NJ, NY, NC, OH, OK, PA,RI, SC, TN, TX, VA, WA, and WI; and countries of: ALGERIA, AUSTRALIA, AUSTRIA, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, LATVIA, LEBANON, MALAYSIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, REPUBLIC OF MOLDOVIA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and YUGOSLAVIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111582LOGIQ S8GE Healthcare · 2011-07-26

Official Source

View FDA Recall →

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