Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52022
  • Event Risk Class
    Class 2
  • Event Number
    Z-1720-2009
  • Event Initiated Date
    2009-05-04
  • Event Date Posted
    2009-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81921
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    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.
  • 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.

Device

Device Recall CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA