• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LOGIQ S8 Ultrasound System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall LOGIQ S8 Ultrasound System see related information
Date Posted August 09, 2013
Recall Status1 Terminated on September 15, 2014
Recall Number Z-1944-2013
Recall Event ID 65583
510(K)Number K111582 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product 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).
Code Information 52SU0
180105SU9
175343SU3
172654SU6
173365SU8
165743SU6
179453SU6
172655SU3
181646SU1
166464SU8
173820SU2
160527SU8
177278SU9
159255SU9
158240SU2
158241SU0
158242SU8
159132SU0
159135SU3
159256SU7
160127SU7
160129SU3
160130SU1
178006SU3
165331SU0
165333SU6
169779SU6
171026SU8
165580SU2
162601SU9
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
262-513-4122
Manufacturer 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
FDA Determined
Cause 2
Software design
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 James.Giles@med.ge.com.
Quantity in Commerce 755
Distribution 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) Database 510(K)s with Product Code = IYN and Original Applicant = GE HEALTHCARE
-
-