| ||Class 2 Device Recall GE Healthcare, Advantage Workstation, READY View Application |
||September 18, 2013
||Terminated on November 21, 2014
|Recall Event ID
System, image processing, radiological -
||GE Healthcare, Advantage Workstation, READY View Application.
Image analysis software.
GE Healthcare, LLC
3000 N Grandview Blvd
|For Additional Information Contact
|GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect
fMRI activation maps may be computed and displayed.
||GE provided Urgent Medical Device Correction letters to consignees in the following countries: Canada, Finland, France, Germany, Guadeloupe, Italy, Japan, Latvia, Martinique, Netherlands, Norway, Poland, Reunion, Romania, Saudi Arabia, Singapore, Spain,Sweden, Switzerland, Turkey and the United Kingdom.
The letters were dated March 27, 2012 and were addressed to Hospital Administrators, Radiology Mangers and Risk Managers. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US 800-437-1171, Japan 0120-055-919 and for other countries contact your local GE Healthcare Service Representative).
*Letters to other consignees is being planned for September 2013.
|Quantity in Commerce
||318 (28 USm 290 OUS)
||Worldwide Distribution-USA including the states of IL, MN, NJ, NY, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GUADELOUPE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN,KOREA, LATVIA, MARTINIQUE, NETHERLANDS, NORWAY, PHILIPPINES,S POLAND, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VIETNAM.
|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 = LLZ and Original Applicant = GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)