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

• Date Initiated by Firm: May 04, 2009
• Date Posted: August 13, 2009
• Recall Status: Terminated on May 16, 2012
• Recall Number: Z-1720-2009
• Recall Event ID: 52022
• 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, 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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, 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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 WI 53188-1615
• For Additional Information Contact: 262-544-3894
• 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: 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 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 = JAK and Original Applicant = GE HEALTHCARE