Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall GE Ultrasound ViewPoint 6

  • 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 GE Ultrasound ViewPoint 6 see related information
Date Initiated by Firm August 07, 2013
Date Posted August 27, 2013
Recall Status1 Terminated 3 on April 25, 2014
Recall Number Z-2098-2013
Recall Event ID 65880
510(K)Number K103458  
Product Classification System, image processing, radiological - Product Code LLZ
Product GE Ultrasound ViewPoint 6.

Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.
Code Information software versions 6.2, 6.2.1, 6.3, and 6.3.1
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
877-644-3114
Manufacturer Reason
for Recall		 GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21,
FDA Determined
Cause 2		 Software Design Change
Action GE Healthcare sent An Urgent Medical Device Correction letter dated August 7, 2013 to all affected customers. The letter described the affected product, problem and instructed customers to discontinue use of venous PIV for making any and all clinical decisions. The letter informed customers that a GE service engineer will install a correction at no cost. For questions contact your local GE Healthcare Representative or call 877-644-3114 (US) and 49 (0)8153-9311-11(Europe/Asia)
Quantity in Commerce 225
Distribution Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: ANDORRA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KUWAIT, MALAYSIA, Norway, OMAN, PALESTINIAN TERRITORY, OCCUPIED, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE
-
-