FDA · Medical device recall

GE Innova 3100 / 3100 IQ… and 5 more products

Sept. 21, 2008

Date posted by the FDA: Sept. 21, 2008
Status: Terminated
Filed by: GE Healthcare
Reason: GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two conditions include 1). Due to insufficient securing of the connecting elements, the LCD vertical monitor support may disengage from its arm and fall on the tab
Distribution pattern: USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA

6 products in this recall

GE Innova 3100 / 3100 IQ…

Product: GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
Quantity: 341
Codes and lots: 00000536885BU7 00000524151BU8 00000807/61010 123100037 1203100026 1203100029 00000507807BU6 00000520244BU5 00000460530BU9 00000469400bu6 00000452842BU8 00000112420VE5 00000469349BU5 00000469380BU0 00000307/50876 00000524122BU9 00000453185BU1 00000460590BU3 00000105/30212 9110080 00000469377BU6 00000504/10092 00000704/20116 00000507774BU8 00000493795BU9 00000307/50891 00000507773BU0 00000460632BU3 00000112399VE1 00000407/50915 00000483688BU8 704120117 00000536842BU8 00000112423VE9 00001004-20153 00000524162BU5 00000536835BU2 00000048698BU7 00000507811BU8 00000807/61019 00000507/50956 00001204/30190 00000507817BU5 00000469368BU5 00001204/30187 00000452891BU5 00000452866BU7 00000707/60982 00001204/30191 00000493809BU8 00000112407VE2 00000112409VE8 00000499188BU1 00000499133BU7 00000507792BU0 00000536845BU1 00000469343BU8 00000524118BU7 00000536848BU5 00000460550BU7 00000524167BU4 00000469355BU2 00000483704BU3 00000520268BU4 00000307/50878 00000407/50910 00000469359BU4 00000112427VE0 00000469354BU5 00000493804BU9 00000604-10104 00000507814BU2 00000453182BU8 00000307/50883 00000460580BU4 00000453184BU4 0000M04/200013 304110059 00000707/60979 00000507770BU6 00000499138BU6 00000307/50900 00000483685BU4 00000520280BU9 00000499152BU7 00000460557BU2 00000469410NU5 00000307/50872 00000536892BU3 00000112414VE8 00000460621BU6 00000520265BU0 00000524152BU6 00000807/61020 00000204/10054 00000499175BU8 00000466696BU2 00000493796BU7 00000507791BU2 00000499157BU6 00000524156BU7 00000536910BU3 00000524153BU4 00000507804BU3 1204930184 00000907/60185 00001004/20148 00000469352BU9 000000M0420A3A 00000306/40566 00000499153BU5 00000453180BU2 00000520271BU8 00000466723BU4 00000105/30152 00000904/20011 00001004/20143 00000507/50940 00000704/20106 00000536855BU0 00000536856BU8 00000452884BU0 00000520239BU5 00001104/20029 00000466690BU5 304110067 00000452853BU5 00000453191BU9 00000469329BU7 00000460626BU5 00000536830BU3 00000499132BU9 00000460602BU6 00000112417VE1 00000704/10107 00000507809BU2 00000452846BU9 00000107/50809 00000536851BU9 00000112425VE4 00000466712BU7 00001005/40426 00000460610BU9 00000112432VE0 00000307/50905 00000520296BU5 00000469347BU9 00000460603BU4 00000507/50935 00000452850BU1 00000307/50893 1203100022 00000536901BU2 00000407/50913 00000452857BU6 00000460559BU8 00000112433VE8 00000536849BU3 00000107/50819 00000536905BU3 00000807/61013 00000105/30213 00000520246BU0 00000520301BU3 00000460614BU1 00000105/30204 00000904/20136 00000507810BU0 00001003/00013 00000507802BU7 00000452887BU3 00000407/50168 00000907/61025 00001007/61036 00000520249BU4 00000452852BU7 00000707/60174 00001107/61043 00001107/61049 00000520275BU9 00001207/61086 00000453189BU3 00000807/61016 00001007/61031 00000108/61111 00001207/61083 00000452825BU3 00000108/61108 00000304/10062 00001007/61041 00000460587BU9 00000460571BU3 00000807/61021 00000452858BU4 00000807/61023 00000704/20104 00001207/61089 00000536890BU7 00000904/20139 00000520282BU5 00000469361BU0 00000707/60977…
Recall started: June 24, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Employee error
What the company told customers: The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
Recall number: Z-2356-2008

GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System…

Product: GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
Quantity: 275
Codes and lots: 00000466713BU5 00000466705BU1 00000524119BU5 00000536916BU0 00000112428VE8 00000460509BU3 00000507823BU3 00000460516BU8 00000469271BU1 00000460505BU1 00000460528BU3 00000466687BU1 00000536866BU7 00000405/40253 00000466707BU7 00000307/50880 00000520248BU6 00000460549BU9 00000307/50896 00000469345BU3 00000112416VE3 00000466740BU8 00000460554BU9 00000469342BU0 00000466739BU0 00000466743BU2 00000466677BU2 00000460504BU4 00000466762BU2 00000307/50866 00000460623BU2 00000407/50914 00000536903BU8 00000707/60983 00000507796BU1 00000524158BU3 00000469363BU6 00000520259BU3 00000536827BU9 00000707/60999 00000466754BU9 00000493790BU0 00000520267BU6 00000112421VE3 00000493801BU5 00000407/50170 00000469344BU6 00000452845BU1 00000112418VE9 00000469335BU4 00000112431VE2 00000807/61017 00000469351BU1 00000460631BU5 00000469312BU3 00000452829BU5 00000520264BU3 00000536837BU8 00000605/00051 00000460609BU1 00000520276BU7 00000112419VE7 00000469370BU1 00000469358BU6 00000493805BU6 00000524117BU9 00000460520BU0 00000466675BU6 00000460511BU9 00000483699BU5 00000536839BU4 00000460615BU8 00000469328BU9 00000207-50843 00000466751BU5 00000469263BU8 00000507/50938 00000524147BU6 00000452812BU1 00000460569BU7 00000452921BU0 00000453224BU8 00000466767BU1 00000460503BU6 00000206/40463 00000524124BU5 00000460597BU8 00000407/50916 40372 00000452901BU2 404110077 00000466684BU8 00000536876BU6 00000536850BU1 00000536913BU7 00000466756BU4 00000469269BU5 00000507813BU4 00000112405VE6 00000112410VE6 00000460576BU2 00000466685BU5 00000466714BU3 00000466671BU5 00000536836BU0 00000108/60209 00000108/61090 00000707/60992 00000452836BU0 00001207/61063 00000907/60631 00000460585BU3 00000460563BU0 00000536904BU6 00000536922BU8 00000469372BU7 00000112447VE8 00000207/50856 00000460562BU2 00000520294BU0 00000707/60614 00000466674BU9 00000452840BU2 00000466734BU1 00000469299BU2 00000452826BU1 00000466700BU2 00000460532BU5 00000452841BU0 00000112452VE8 00000469302BU4 00000469244BU8 00000453158BU8 00000466735BU8 00000469224BU0 00000469282BU8 00000112400VE7 00000607/50602 00000469297BU6 00000466717BU6 00000524113BU8 00000507/50957 00000452927BU7 00000112436VE1 00001007/61039 00001007/61038 00000493808BU0 00000460510BU1 00000469272BU9 00000466681BU4 00000469288BU5 00000807/50176 00000520293BU2 00000469289BU3 00000469294BU3 00000469256BU2 00000469275BU2 00000460589BU5 00000536838BU6 00000460538BU2 00000466752BU3 00000307/50881 00000520274BU2 00000507/50950 00000520257BU7 00000524135BU1 00000507781BU3 00000507775BU5 00000536865BU9 00000707/50970 00000524161BU7 00000507797BU9 00000507784BU7 00000469401BU4 00000450567BU1 00000524143BU5 00001107/61052 00000469245BU5 00000806/00082 00000907/00156 00000460540BU8 00000460531BU7 00000460605BU9 00000112449VE4 00000607/50967 00000466730BU9 00000460526BU7 00000507/50922 00000469375BU0 00000460542BU4 00000469325BU5 00000499146BU9 00000499147BU7 00000520292BU4 00000469238BU0 00000460553BU1 00000469257BU0 00000520298BU1 00001107/61050 00000469259BU6…
Recall started: June 24, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Employee error
What the company told customers: The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
Recall number: Z-2357-2008

GE Innova 4100 / 4100 IQ…

Product: GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
Quantity: 252
Codes and lots: 00000469348BU7 00000536877BU4 404110063 00000452883BU2 00000504/10096 00000460596BU0 00000469365BU1 00000704/20115 704120114 00000536912BU9 00000460572BU1 00000052416BU0 00000460630BU7 00000307/50895 120310008 00001104/20158 00000507/50928 00000460594BU5 00000452882BU4 00000453177BU8 00000461253BU7 00000307/50879 20116 00001004/20116 00000307/50884 1003100012 00000536843BU6 00000469338BU8 00000112413VE0 50410084 00000452854BU3 00000453150BU5 00000453167BU9 00000524168BU2 904120023 00000452892BU3 00000112412VE2 00000524121BU1 00000469322BU2 00000112461VE9 00000507/50921 00000507767BU2 00000469371BU9 00000112408VE0 00000905/40399 00000453140BU6 00000907/61022 00001003/00003 00000469364BU4 1203100039 00000452885BU7 00000469346BU1 404110064 00000452862BU6 00000507812BU6 00000499183BU2 00000499131BU1 00000483701BU9 00000452873BU3 1203100032 00000466706BU9 0000066706BU94 00000452871BU7 00000536900BU4 00000112403EV1 00000112403VE1 1203100034 1003 00000453165BU3 00000469337BU0 404110079 00000469264BU6 00000466763BU0 00000520277BU5 110310015 00000469330BU5 00000524129BU4 00001004/20145 00000404/10086 104100047 304110017 00000GD60U6-GE 00000904/20130 00000453213BU1 00000469394BU1 1103100020 00000461251BU1 1203100033 110420162 00000469367BU7 00000466688BU9 00000469381BU8 00000469350BU3 00000460560BU6 504110085 00000112397VE5 00000307/50868 00000507832BU4 00000307/50877 00000452828BU7 00000524154BU2 00000GD60U4-GE 00000469407BU1 904 00000524163BU3 00000460611BU7 00000466709BU3 00000460579BU6 00000104/00046 00000461252BU9 00000460568BU9 0000CA04110576 00000112434VE6 00000466755BU6 00000704/20106 00000520281BU7 00000499151BU9 00000469227BU3 00000469240BU6 00000460591BU1 00000104/00042 1204130176 00000499150BU1 00000507805BU0 00000452848BU5 604120099 00000307/50886 00000105/30203 00000105/32203 00000452880BU8 00000907/60635 1204130198 00000307/50885 00000469310BU7 00000804/20123 00001003/00007 1003100004 00000507815BU9 00000493792BU6 00000105/30201 00000460570BU5 00000507/50937 00000707/60995 00000461250BU3 00000524155BU9 00000507771BU4 00000524137BU7 00000452861BU8 00000507818BU3 00000104/00048 00000404/10074 00001204/30196 00000112398VE3 00000520251BU0 00000520278BU3 00001207/61080 00000507766BU4 00000805/40266 00000469317BU2 00000404/16671 00001207/61071 00000108/61116 00001207/60662 00001207/61067 00001104/20129 00000807/61014 00000108/61106 00000524114BU6 00000452811BU3 00001207/61087 00001007/61035 00001207/61064 00000460601BU8 00001207/60196 00001207/61081 00000453211BU5 00000469273BU7 00000108/61099 00000460577BU0 00000466745BU7 00000404/10066 00000707/60981 00000452879BU0 00000707/61001 00000453170BU3 00001004/20119 00001007/61034 00000108/61095 00000707/60988 00000707/61000 00001004/20146 00000460618BU2 00001207/60200 00000536872BU5 00000507/50931 00000507/50932 00000520299BU9 00001206/30188 00000507793BU8 00001104/20170 00000307/50888 00000536917BU8 00000524164BU1 00000452800BU6 00000507827BU4 00000469305BU7 00000520242BU9 00000507/50951 304110070…
Recall started: June 24, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Employee error
What the company told customers: The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
Recall number: Z-2358-2008

Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic angiographic…

Product: Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.
Quantity: 62
Codes and lots: 00001104/20163 00000453208BU1 00000604/20009 00000452923BU6 00001104/20026 1003000011 106100046 304110016 00000483694BU6 1103100017 00000483695BU3 00001004/20125 00000452904BU6 00000905/40049 50410007 00000904/20132 00000904/20010 00001103/20127 00000404/10003 00000466738BU2 1203100011 00000453217BU2 00001103/00006 00000045295BU1 1203100009 120340010 00000461244BU6 00000499182BU4 00000453148BU9 00000460515BU0 00000461241BU2 00001204/30194 00000453153BU9 00000705/40244 00000452906B01 00000452906BU1 00000453194BU3 00000453146BU3 00000604/20019 00000466737BU4 00001107/61054 00000453132BU3 00000453154BU7 00000453156BU2 00000453161BU2 00000469231BU5 00000452821BU2 00000461245BU3 00000112406VE4 00000461242BU0 00000453152BU1 00000461246BU1 00000461247BU9 00000461243BU8 00001107/00019 00000469389BU1 00000452835BU2 00000466670BU7 00000469265BU3 00000466721BU8 00000453149BU7 and 00000453216BU4
Recall started: June 24, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Employee error
What the company told customers: The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
Recall number: Z-2359-2008

Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System…

Product: Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment.
Quantity: 26 + 537 (system not installed therefore product not stated)
Codes and lots: 00000483707BU6 00000452932BU7 00000208/00036 00000452935BU0 00001107/00021 00000907/00004 00000208/00039 00001107/00016 00001007/00009 00000707/00001 00000907/00003 00000907/00008 00001007/00014 00000907/00010 00000907/00003 00000907/00005 00000907/00009 00000208/00035 00000907/00007 00001107/00012 00000907/00006 00001007/00011 00000907/00002 00000452928BU5 00000208/00033 00001107/00022 Unknown 00000536861BU8 00001007/60645 00001107/61044 00000907/60638 00000105/30208 00000469378BU4 00000524123BU7 00000604/10099 00000460514BU3 00000536894BU9 204110064 304110062 304110071 404110070 404110087 00000105/30033 00000105/30151 00000105/30154 00000105/30155 00000105/30202 00000105/30205 00000108/00027 00000108/00029 00000108/00030 00000108/60206 00000108/60207 00000108/60210 00000108/60673 00000108/60675 00000108/60676 00000108/60677 00000108/61091 00000108/61104 00000108/61105 00000108/61107 00000108/61109 00000108/61110 00000108/61113 00000108/61114 00000108/61115 00000108/61119 00000108/61120 00000108/61121 00000108/61124 00000108/61125 00000108/61128 00000108-60206 00000112404VE9 00000112422VE1 00000112426VE2 00000112429VE6 00000112443VE7 00000112457VE7 00000112458VE5 00000112460VE1 00000112465VE0 00000208/00038 00000208/60681 00000208/60682 00000208/60683 00000208/60685 00000307/50892 00000307/50904 00000307/50907 00000407/50167 00000407/50171 00000407/50595 00000407/50911 00000452806BU3 00000452807BU1 00000452809BU7 00000452813BU9 00000452823BU8 00000452837BU8 00000452855BU0 00000452860BU0 00000452864BU2 00000452865BU9 00000452869BU1 00000452870BU9 00000452872BU5 00000452875BU8 00000452878BU2 00000452895BU6 00000452905BU3 00000452907BU9 00000452916BU0 00000452918BU6 00000452922BU8 00000452925BU1 00000452926BU9 00000452933BU5 00000453142BU2 00000453160BU4 00000453162BU0 00000453166BU1 00000453169BU5 00000453173BU7 00000453174BU5 00000453175BU2 00000453178BU6 00000453183BU6 00000453187BU7 00000453188BU5 00000453195BU0 00000453222BU2 00000453227BU1 00000460507BU7 00000460512BU7 00000460513BU5 00000460521BU8 00000460522BU6 00000460524BU2 00000460525BU9 00000460527BU5 00000460539BU0 00000460544BU0 00000460546BU5 00000460551BU5 00000460552BU3 00000460555BU6 00000460556BU4 00000460573BU9 00000460582BU0 00000460583BU8 00000460586BU1 00000460588BU7 00000460592BU9 00000460595BU2 00000460600BU0 00000460606BU7 00000460607BU5 00000460612BU5 00000460616BU6 00000460619BU0 00000460622BU4 00000460627BU3 00000460628BU1 00000460629BU9 00000466668BU1 00000466669BU9 00000466672BU3 00000466673BU1 00000466676BU4 00000466680BU6 00000466683BU0 00000466748BU1 00000466753BU1 00000466764BU8 00000466765BU5 00000469267BU9 00000469268BU7 00000469285BU1 00000469309BU9 00000469314BU9 00000469316BU4 00000469321BU4 00000469326BU3 00000469334BU7 00000469340BU4 00000469341BU2 00000469353BU7 00000469357BU8 00000469366BU9 00000469369BU3 00000469382BU6 00000469400BU6 00000469405BU5 00000469406BU3 00000469408BU9 00000469409BU7 00000469410BU5 00000469411BU3 00000469412BU1 00000469413BU9…
Recall started: June 24, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Employee error
What the company told customers: The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
Recall number: Z-2360-2008

Innova 2000 The principle system components include a C-arm…

Product: Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment..
Quantity: 135
Codes and lots: 00000108/61094 1003100013 0000010031000L 00000452818BU8 00000704/20108 1103100019 1103100019 00000404/10070 104100053 104100051 104100057 00000452834BU5 1104120128 00000452889BU9 00000452890BU7 00000524134BU4 00001104/20167 909110081 1103100025 00000452863BU4 000005041A0050 0000904/201135 00000405/40184 00001104/20157 00000704/20105 00000452867BU5 00000604/10092 00000452856BU8 1103100021 00000569/100S1 204110065 00000452886BU5 00000607/60971 00000469421BU2 106100066 1003100009 00000453141BU4 00001204/30186 00001104/20172 00000466711BU9 00000704/20102 00000469228BU1 1103100017 00000707/50172 30177 100300002 110300023 1103100026 00001003/00002 00001103/00023 00000452894BU9 609110902 00000304/20129 00000404/10078 00000704/20112 00000105/30149 00000466679BU8 104100050 00000707/60998 00000469313BU1 00000307/50908 00000807/61002 00000805/40289 00000452817BU0 00001207/61076 00000105/30150 00000469278BU6 00001004/20007 00001207/60203 00000469262BU0 00001207/61070 00000524144BU3 00000807/61012 00000469252BU1 00000707/50611 00000524120BU3 00000807/61005 00000805/40263 00001107/60651 00000405/40252 00001003/00006 00000453164BU6 00001204/30189 204110049 00000536915BU2 00000452844BU4 00001204/30200 00000507826BU6 00000536925BU1 00000460519BU2 00000466701BU0 00000452849BU3 1203100025 00000104/00052 00000452839BU4 00000536863BU4 00000460617BU4 00000452815BU4 00000452838BU6 1203100041 304110072 24110061 204110061 00000466746BU5 00001003/00012 00001203/00035 00000453138BU0 110360007 00000104-00014 00001004/20150 00000604/20095 00000604/20098 00000704/20111 00000453136BU4 00000453179BU4 00000452868BU3 00000452797BU4 00000461248BU7 00001204/30197 00000104/00044 00001204/30147 00000460593BU7 1203100038 00000466744BU0 00000452810BU5 704120118 00000452819BU6 00000507/50936 00000604/10087 00000112450VE2 00000460543BU2 00001003/00008 00000452816BU2 00000499172BU5 and 00000499169BU1
Recall started: June 24, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Employee error
What the company told customers: The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
Recall number: Z-2361-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-2356-2008, Z-2357-2008, Z-2358-2008, Z-2359-2008, Z-2360-2008, Z-2361-2008. The agency record governs; check it and the company before acting.

Report a mistake on this page