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U.S. Department of Health and Human Services

Class 2 Device Recall CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles

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 Class 2 Recall
CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles
see related information
Date Posted August 13, 2009
Recall Status1 Open
Recall Number Z-1720-2009
Recall Event ID 52022
Premarket Notification
510(K) Number
K052839 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images.
Code Information Serial Numbers: 00000152741GE5, 00000152737GE3, 00000134590GE9, 00000119522GE1, 00000119523GE9, 00000146655GE6, 00000146668GE9, 00000146669GE7, 00000119519GE7, 00000145765GE4, 00000152738GE1, 00000121182GE0, 00000122793GE3, 00000119517GE1, 00000139086GE3, 00000141801GE1, 00000141802GE9, 00000141803GE7, 00000141804GE5, 00000141805GE2, 00000119521GE3, 00000118133GE8, 00000118134GE6, 00000118135GE3, 00000121180GE4, 00000141807GE8, 00000119516GE3, 00000123926GE8, 00000123931GE8, 00000122794GE1, 00000127524GE7, 00000127525GE4, 00000129247GE3, 00000134588GE3, 00000123927GE6, 00000123929GE2, 00000119520GE5, 00000122797GE4, 00000122795GE8, 00000123930GE0, 00000127522GE1, 00000127523GE9, 00000129243GE2, 00000127520GE5, 00000127521GE3, 00000127526GE2, 00000139088GE9, 00000129246GE5, 00000145645GE8, 00000141808GE6, 00000141811GE0, 00000151783GE8, 100995344, 00000145642GE5, 00000145647GE4, 00000118132GE0, 00000122799GE0, 00000122800GE6, 00000123928GE4, 00000127519GE7, 00000152735GE7, 00000129244GE0, 00000129245GE7, 00000129248GE1, 00000129249GE9, 00000129250GE7, 00000129251GE5, 00000134584GE2, 00000134585GE9, 00000134586GE7, 00000134587GE5, 00000145649GE0, 00000152742GE3, 00000122798GE2, 100995241, 100995217, 100995259, 80521349, 100995302, 100995275, 100995276, 100995431, 100995326, 100995412, 100995322, 80515302, 80515303, 80523248, 100995352, 100995298, 100995359, 100995306, 100995268, 100995354, 0CC08041501002, 0CC08041501003, 100995225, 80528332, 80521354, 100995279, 100995280, 100995281, 100995282, 100995283, 100995297, 100995305, 100995308, 100995288, 100995340, 100995355, 100995361, 100995385, 100995356, 100995450, 100995227, 80528736, 0CC08041501009, 80528724, 100995242, 100995351, 100995211, 100995212, 100995383, 80527216, 80527225, 80515730, 80528335, 80515721, 80521344, 80528730, 80528741, 80521352, 80521350, 80523251, 80521348, 100995222, 80515722, 100995339, 00000134592GE5, 00000134591GE7, 80505225, 80505229, 0CC08041501005, 80528328, 80528336, 80529188, 80521353, 100995224, 100995218, 100995221, 100995360, 100995240, 100995266, 100995267, 100995274, 80528329, 80528327, 00000121178GE8, 00000141809GE4, 00000152739GE9, 00000155218GE1, 00000121179GE6, 0CC08041501008, 100995239, 100995294, 100995327, 80528734, 100995366, 80515727, 80528322, 80521355, 100995278, 100995328, 100995331, 100995396, 100995411, 100995420, 00000146658GE0, 80528723, 80528324, 80505223, 80505226, 80505228, 100995220, 80528325, 0CC08041501007, 80527223, 80515296, 80528731, 80527219, 100995408, 0CC08041501010, 80528733, 80528735, 80528732, 80529189, 80521356, 100995311, 100995364, 100995219, 100995271, 100995292, 100995338, 100995334, 100995336, 100995286, 100995350, 100995379, 100995317, 100995318, 100995413, 100995449, 100995375, 80523250, 80515297, 80521351, 80528326, 0CC08041501004, 100995205, 80521343, 0CC08041501001, 100995270, 80505230, 80527218, 100995265, 100995300, 100995400, 100995426, 100995433, 80527224, 100995330, 100995341, 100995378, 100995291, 80528323, 0CC08041501006, 80505227, 100995377, 100995295, 100995272, 100995312, 100995368, 100995284, 100995349, 100995245, 80528330, 100995289, 100995255, 100995256, 100995374, 100995406, 100995319, 100995415, 100995409, 100995401, 100995332, 100995325, 100995419, 100995405, 100995407, 100995427, 100995429, 100995417, 80523253, 80528333, 00000145766GE2, 00000145644GE1, 80515298, 100995260, 0CC08040101001, 100995249, 100995388, 100995425, 100995229, 80523247, 100995209, 80528337, 100995296, 80515724, 80528339, 80505231, 80528739, 80515723, 80528340, 80515725, 80529195, 100995244, 80523249, 80515728, 80515729, 100995348, 100995370, 100995410, 100995376, 80529190, 80529191, 80529192, 80515726, 80529186, 80523246, 80528338, 80527222, 80529194, 80529193, 80528725, 80521346, 80528331, 80528334, 80528321, 80521347, 100995250, 100995251, 100995252, 100995254, 100995342, 000005189396-2, 100995223, 80523252, 100995215, 100995236, 100995231, 100995233, 100995232, 100995234, 100995237, 100995230, 100995235, 100995247, 100995304, 100995269, 100995273, 100995258, 100995285, 100995337, 100995287, 100995246, 100995314, 100995264, 100995387, 100995343, 100995365, 100995390, 100995392, 100995394, 100995391, 100995393, 100995384, 100995329, 100995404, 100995395, 100995402, 80528740, 80528737, 80527217, 80527221, 80528726, 80528727, 80528728, 100995316, 100995345, 100995353, 100995367, 80505224, 80505232, 100995207, 00000146661GE4, 00000144815GE8, 00000146660GE6, 00000146662GE2, 100995418, 100995441, 100995416, 00000146664GE8, 00000146666GE3, 00000146665GE5, 00000146659GE8, 100995238, 80529187, 100995208, 80523254, 100995214, 100995213, 100995206, 80515301, 80515305, 80527220, 100995253, 80523255, 100995210, 80515299, 80515304, 100995226, 100995257, 100995323, 100995228, 100995248, 100995262, 100995362, 100995301, 100995307, 100995309, 100995310, 100995299, 100995346, 100995403, 100995373, 100995363, 100995389, 100995422, 100995380, 100995381, 100995434, 00000145763GE9, 00000134589GE1, 00000121181GE2, 00000119518GE9, 00000151784GE6, 00000134583GE4, 00000141810GE2, 00000145641GE7, 00000145640GE9, 00000145768GE8, 00000145764GE7, 00000145767GE0, 00000151782GE0, 00000139087GE1, 00000145643GE3, 00000151780GE4, 00000151781GE2, 00000152740GE7, 00000152736GE5, 00000145646GE6, 00000145648GE2, 100995263, 100995243, 100995261, 100995421, 100995436, 100995435, 100995423, 100995424, 00000118131GE2, 00000141806GE0 and 00000118136GE1.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater th
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 23, 2009. The letter was addressed to Hospital Administrators / Risk managers and Radiology department mangers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information instructing the user to follow the enclosed User Guide Addendum to mitigate further problems. For further questions, contact GE Healthcare at 1-800-437-1171 (US), 0120-055-919 (Japan); for other countries, contact your local GE Healthcare field service representative.
Quantity in Commerce 444
Distribution Worldwide Distribution -- Including states of AZ, CA, CT, DC, FL, HI, IL, IA, MA, MI, NJ, NY, NC, OK, PA, PR, TX, WA, WV and WI and countries of ARGENTINA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PAKISTAN, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM and VENEZUELA.
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 = JAK and Original Applicant = GE HEALTHCARE
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