| ||Class 2 Device Recall LOGIQ S8 Ultrasound System |
||August 09, 2013
||Terminated on September 15, 2014
|Recall Event ID
System, imaging, pulsed doppler, ultrasonic -
||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).
GE Healthcare, LLC
3000 N Grandview Blvd
|For Additional Information Contact
|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
||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 James.Giles@med.ge.com.
|Quantity in Commerce
||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.
|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)s with Product Code = IYN and Original Applicant = GE HEALTHCARE