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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Advantage Workstation, READY View Application

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 Class 2 Device Recall GE Healthcare, Advantage Workstation, READY View Application see related information
Date Posted September 18, 2013
Recall Status1 Terminated on November 21, 2014
Recall Number Z-2241-2013
Recall Event ID 66111
510(K)Number K110573 
Product Classification System, image processing, radiological - Product Code LLZ
Product GE Healthcare, Advantage Workstation, READY View Application.

Image analysis software.
Code Information 0001
0000BA11200002
00000Z11299004
00000T11291001
00000Q11342001
0000AP11116001
0000BC11167001
000000010047GS
0000AE11242001
00000L3AAEC8F5
00000L3AB2DBBA
000000010029GS
00000L3AAEC8A9
00000L3AA81CE5
000000010045GS
00000L3AB68EE4
000000010044GS
00000E11248007
0000CZC1456R18
00000L3AB2DF9E
00000L3AB04721
00000L3A77E646
00000Z11280001
0000AK11081001
0000AA11187001
00000V11361001
00000V11361002
00000V11361003
00000X12023001
00000206069HP7
000000010051GS
0000BC11167005
00000S11312002
0000AV11249004
0000AV11249005
00000Q11342002
00000L3AB68EFF
00000L3AB7CC7C
0000BH11122001
0000BH11122003
00000Z11280002
0000AE12026002
00000S11312009
00000S11312010
00000L3AB7CC6E
00000Q11076005
00000Q11076006
00000Q11076001
00000Q11076002
00000Q11076003
00000Q11076004
0000AK11081003
0000AF11256002
0000AF11256003
00000Y12030001
0000AD11350002
00000L3AB04510
00000L3AB68F20
00000LE23E906A
000000010048GS
0000AA11363003
000000010041GS
00000L3AB677C5
00000L3A99855B
00000L3AB68DA1
0000AE11242005
0000AE11242006
00000Q11076009
00000L3AB68D48
00000Y11104001
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 has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
FDA Determined
Cause 2
Software design
Action 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)
Distribution 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) Database 510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
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