Devices

Device Recall Innova

  • Modelo / Serial
    System ID 2036884100A 6029234100 201541SP1 2035764100 205759CL2 215662INNOVA1 216844INNOVA 219326IN41 2194654100 228809VASC 228VA4100 229228INNOV41C 229228INNOV41V 22925941V 22925941V2 229312IN41OR 229434INNOV 239436CATH1 248849SP1 251435I12 251435ICV5 252816INNOVA 252847PRS2 256429SV1 269226IN1 269226IN2 269983IN41 281401T4100 3018774100 303320OR41 303399IR 303436ANGIO2 303839ANGIO1 303839ANGIO2 303839CL1 304256INNOVA 304347INNOVA 305823IN4100 308534ANG 309343CSP1A 309655FSP1A 309672M4100 312792R4100 313343SP1 313876SP41 314966DPHSP 315448RM4 315448RM5 316962INNOVA41 317887INNOVAPV 3184734100 318681INNOVA1 319338VA4100 325670CATH 330489ORVASC 334286BSP 337981INNOVA 352333INVOR 352333VASC 352376SP 352401CATH 352401VASC 360754INNOVA 386254HS1 401274IN41 404466SF41A 404712SP12 404GHSIR1 404GHSIR2 407518SP2 407518SP3 407SPECIALS 4082594100 409212INOV41 4103374100 410337INNOVA2 4105434100 412623LAB1 412623LAB3 412647OR10 412784LAB1 4134474100 4135344100 4137484100 414328INN4100 414961INN4100 419696LAB1 443481ANGIO1 4436434100 4438434100 4438494100 443849INNOVA 478633INOV 480512SP 5033704100 505848CATH2 505848V4100 508856OR41 5094744100 509474SH41 509482HFI 512528CPCL1 512901NI4100 5135844100 5136864100 5138534100 515263IL4100 516562INNOVA4 516632INNOVA8 541282CV2 541686SPR1 5417684100 561548VAS2 561747IN4 561776IN41 561784INSP 570321LAB2 5705224100 573632CRA 573761SMA 574535IN41 574647IN41 586573SP1 6012884100SP1 6029234100 603650ANG1 605333RM10 606833INNOVA 6082634100 608263ACT 608263XMR 608324DAL 609652CATH3 609757IN4100 610954INNOVA41 614293LIBERTY1 614293LIBERTY2 614722INNOVA1 615284OR15 615342CV7 617636IN1 617726RF2Y6 619229INNOVA1 623207SP 626359INNOVA 630275G41B 650369SV5 650493ANGIOCT 6616324100 662244GTSP 678EJCIR1 7028804100 704487CR41 706278INNOVA1 706291RINN 706651SP1 706724VRA4100 706733SP1 706774USP3 706802FINN 708202VA41 7087564100 708783SP4100 708WESTSUB4100 713375U4100 7137764100 715369INN4100 717763INNOVA41 717763OR4100 717782DVD1 718206LIBERTY1 718250ANGIO 718518CVL1 718630LIBERTY 724656ANG 727725SPEC1 727791INNOVA 757398INNOVA 757736INNOVA 757889INNOVA 773878SWGANGIO1 77573841 801268INNOVA 80140841 80158241 80180741 802295VALCA 803329CL41 804285CATH2 804594ANGIO 804594CATH 804764CATH3 810342A41 812238UN41 812279INNOVA1 813558INTV 813615CL10 815740SC4100 8159374100 816276SP1 816943SP1 817255NH4100 817433HSW4100 828298VASC 828696IN41 843577CL2 843674VAS1 843674VAS2 843789SP1 845368RM10 8458584100 847316INNOVA41 847842GS4100 850494WSP1 850747IN4100 856365ANGIO 8565961N4100 858939IR9 8593134100 8595724100 863687INV24 864255SF4100 865373SP 865541CCL5 865693CCL3 901726SP2 903CSM4100 903GS4100 904202SP1 904202SP2 904276SP 904BSSP 906485ANGIO 910907WAVAS1 915577SP1 915577SP2 918307SHIN4 918494SFSP41 918682IN41 918744JC4100 937352IN4100 9408984100 941483INNOVA41 954MW4100 956632INN4100 970247INNOVA 972335LIB 972487ANGIO1 972566INNOVA3 985867INNOVA2 989466INNOVA ECXV1406E FHORL4100 FWANG3217 MIRAMAR41 PEMBROKE4100 RADNETXV2 SLIN4100 WCATHLAB41 0853060187 0853060196 06004VAS02 06063VAS01 0856060099 SK1110VA02 E001RX08 SA1188VA03 RU1018VA03 RU1050VA03 RU1063VA01 RU1106VA02 RU1283VA01 RU1326VA01 RU1581VA01 RU2526VA01 RU2992VA01 RU3105VA01 787653INNOVA 600050VA01 NO1015VA04 NO1017VA03 NO1018VA02 NO1064VA04 BRD0411 MA1020VA01 MA1251VA01 LT4001VA02 KW1001VA03 KW1013VA01 0850060707 0850060720 0850060725 XF0160 YV0014 XF0022 XF0149 XF0150 XF0151 XF0156 XF0250 YV0001 YV0002 YV0003 YV0004 YV0005 YV0006 YV0007 YV0009 A5105151 A5123529 A5605732 A5630803 A5630803 C5603903 083016282100259 082406310005 082416040020 0828160011 0828160012 083016002000488 0850060721 IE1100VA01 HU1039VA02 00065VAS01 00084VAS02 00095VAS07 00137VAS01 00171VAS01 A9793314 R4211476 FI1015VA01 DE188442 DE641223 407953XR01 HC1819XR09 UC1129XR33 600002VA01 CS1054VA01 CS1226VA01 250370INNOVA 306766INNOVA 4163694100 416756INNOVA 514376INNOVA 514934BANGIO 519663INNOVA2 519685INNOVA 613548INNOVA3 082406010013 082406150009 082406010011 082406040022 082406070010 082406100018 082406120016 082416030007 082416040021 082416100016 082416130010 082416130011 082416130012 082416130013 082416140005 082416160005 082416160010 082416220006 BY4020VA01 2726801 BG4037XR01 190020RX09 BA4073VA01 0910063039 3882643438CTNOR
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and YUGOSLAVIA.
  • Descripción del producto
    Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system
  • Manufacturer
    GE Medical Systems, LLC
  • 1 Event

Fabricante

GE Medical Systems, LLC
  • Dirección del fabricante
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA

92 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Innova 2100IQ with InnovaIQ Table Option
  • Modelo / Serial
    00000553797BU2, 00000000075WV2, 00000000112WV3, 00000000153WV7, 00000000146WV1, 00000000023WV2, 00000000162WV8, 00000000079WV4, 00000000149WV5, and 00000000033WV1.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.
  • Descripción del producto
    Innova 2100IQ system with InnovaIQ Table Option || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, || rotational imaging procedures.
  • Manufacturer
    Ge Healthcare, Llc
Device Recall Innova 3100/ 3100IQ with InnovaIQ Table Option
  • Modelo / Serial
    00000008C20323, 00000519107BU7, 00000007C20116, 00000464098BU3, - 00000000057WV0, 00000000086WV9, 00000000130WV5, 00000000050WV5, 00000000083WV6, 00000000193WV3, 00000000203WV0, and  00000000076WV0.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.
  • Descripción del producto
    Innova 3100/ 3100IQ system with InnovaIQ Table Option || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, || rotational imaging procedures.
  • Manufacturer
    Ge Healthcare, Llc
Device Recall Innova 4100/4100IQ with InnovaIQ Table Option
  • Modelo / Serial
    00000008C20212 00000453925BU0 00000000200WV6 00000000154WV5 00000000077WV8 00000000150WV3 00000000127WV1 00000000084WV4 00000000040WV6 00000000046WV3 00000000148WV7 00000000051WV3 00000000169WV3 00000000133WV9 00000000145WV3 00000000080WV2 00000000034WV9 00000000088WV5 00000000147WV9 00000000037WV2 00000000035WV6 00000000052WV1 00000000129WV7 00000000141WV2 00000000113WV1 00000000055WV4 00000000189WV1 00000000131WV3 00000000190WV9 00000000022WV4 00000000087WV7 00000000163WV6 00000000230WV3 00000000134WV7 00000000058WV8 00000000044WV8 00000000043WVO 00000000144WV6 00000000140WV4 00000000164WV4 00000000152WV9 00000000039WV8 00000000136WV2 00000000025WV7 00000000139WV6 00000000199WV0 00000000041WV4 00000000024WV09 00000000054WV7 0000000165WV10 00000000198WV2 0000000191WV70 00000000156WV0 00000000157WV8 00000000211WV3 00000000132WV1 00000000026WV5 00000000158WV6 00000000205WV5 00000000143WV8 00000000049WV7 00000000168WV5 00000000078WV6 00000000240WV2 00000000210WV5 00000000160WV2 00000000085WV1 00000000036WV4, and  00000000038WV0.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.
  • Descripción del producto
    Innova 4100/4100IQ system with InnovaIQ Table Option || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, || rotational imaging procedures.
  • Manufacturer
    Ge Healthcare, Llc
Device Recall Innova 2000 Digital Flouroscopic Imaging System
  • Modelo / Serial
    Serial 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  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: States of AL, AZ, AR, CA, CO, CT,DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV,NH, NJ, NM, NH,NC, ND, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and countries of VENEZUELA, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, JORDAN, JAPAN, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT , ECUADOR, COLOMBIA, CHINA, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ALGERIA.
  • Descripción del producto
    Innova 2000, manufactured by GE Medical Systems, SCS
  • Manufacturer
    GE Healthcare, LLC
Device Recall Innovate Esmark Bandages
  • Modelo / Serial
    The Esmark bandages were a component of the following Presource Convenience Packs/Modules: Cat #PO12AUGUT, lot 9097; Cat #PO12HNGUQ, lot 9275; Cat #PO33FAPSF, lot 634802; Cat #PO53TKDMF, lot 633697; Cat #PO56TK48S, lot 634508; Cat #POMHTKWDI, lot 635911; Cat #POOCUEENK, lot 10301516; Cat #SBA11PHSLG, lot 10863; Cat #SBA32VCPAQ, lot 637321; Cat #SBA32VEMEG, lots 638023 and 634732; Cat #SBACGAAAUC, lot 986893; Cat #SBACZEXBRB, lot 633928; Cat #SCV15ACFSF, lot 634357; Cat #SOP08EPDMC, lot 985889; Cat #SOP11APCPZ, lot 8199; Cat #SOP11ARNHT, lot 10004; Cat #SOP11ATMTI, lot 634538; Cat #SOP11BKRJG, lots 9615 and 6734; Cat #SOP11ETCHA, lot 10627; Cat #SOP11EXMML, lot 9036; Cat #SOP11EXNYL, lot 10778; Cat #SOP11FASLD, lot 634159; Cat #SOP11FMLHN, lot 10708; Cat #SOP11FTJHK, lot 10593; Cat #SOP11FTSHO, lot 10244; Cat #SOP11HASWB, lot 9609; Cat #SOP11HDNSF, lot 9062; Cat #SOP11HNFHK, lot 634172; Cat #SOP11HNLDL, lot 10467; Cat #SOP11HNMOM, lot 8839; Cat #SOP11HNMUF, lot 9767; Cat #SOP11HNNBO, lot 9632; 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Cat #SOP21KNSTB, lot 8140; Cat #SOP21TKHOC, lot 10023; Cat #SOP22FTSMP, lot 635580; Cat #SOP22KAMCI, lot 9023; Cat #SOP23ACBSA, lot 9966; Cat #SOP23ACUCO, lot 8999; Cat #SOP23APUCS, lot 10003; Cat #SOP23ARMZD, lot 635735; Cat #SOP23ATGMC, lot 9317; Cat #SOP23EXDUY, lot 9119; Cat #SOP23FTGME, lot 8493; Cat #SOP23HDVAI, lot 9045; Cat #SOP23HNRCQ, lot 636310; Cat #SOP23KTSMA, lot 9455; Cat #SOP23L1DUS, lot 9724; Cat #SOP23LMUCR, lot 10086; Cat #SOP23UPPCE, lot 9456; Cat #SOP23UXHWE, lot 8795; Cat #SOP24KAPSE, lot 633735; Cat #SOP29EXCFJ, lot 635695; Cat #SOP29HDUMA, lot 635594; Cat #SOP29HNMEC, lot 634278; Cat #SOP31ACOSI, lot 987042; Cat #SOP31AHSAE, lot 633267; Cat #SOP31ATMDD, lot 986850; Cat #SOP31EXLSD, lot 636577; Cat #SOP31EXNWL, lot 986251; Cat #SOP31EXRSG, lot 986895; Cat #SOP31EXSFT, lot 986268; Cat #SOP31EXSSF, lot 986831; Cat #SOP31HDCDI, lot 635667; Cat #SOP31HNEVU, lot 986962; Cat #SOP31HNSFU, lot 986275; Cat #SOP31KAMNH, lot 986943; Cat #SOP31KAOSO, lot 985700; Cat #SOP31KPEZB, lot 986891; Cat #SOP31PDJUA, lot 986837; Cat #SOP31RADGF, lot 984976; Cat #SOP31XTDSL, lot 985606; Cat #SOP32ATFSN, lot 635190; Cat #SOP32EXFCD, lot 986432; Cat #SOP32EXPAO, lot 635212; Cat #SOP32HARMI, lot 637186; Cat #SOP32HNMNN, lot 987081; Cat #SOP32HNWBO, lot 634987; Cat #SOP32KECYF, lot 986845; Cat #SOP32PDPCB, lot 635003; Cat #SOP32TKFSN, lot 637532; Cat #SOP32TKSAF, lot 633920; Cat #SOP33EXSFE, lot 985937; Cat #SOP33HDDWH, lot 635158; Cat #SOP34ACSTH, lot 636002; Cat #SOP34ARSKA, lots 985378 and 986541; Cat #SOP34TJHCD, lot 986839; Cat #SOP35ARCRJ, lot 985010; Cat #SOP35HDSTI, lots 986853 and 987204; Cat #SOP36ARAGQ, lot 9791; Cat #SOP36HACOD, lot 10586; Cat #SOP36HAFBQ, lot 9091; Cat #SOP36HNALR, lot 10257; Cat #SOP36KASRC, lot 9930; Cat #SOP36TKFBO, lot 10663; Cat #SOP36TNCAE, lot 9112; Cat #SOP3IKPIPD, lot 633880; Cat #SOP40PDDOG, lot 9098; Cat #SOP41HAMBC, lot 635589; Cat #SOP41HANSC, lot 635498; Cat #SOP41HFSUF, lot 635157; Cat #SOP41HNHMK, lot 9518; Cat #SOP41KNSOC, lot 634860; Cat #SOP41LEMBD, lot 636245; Cat #SOP41UEHMJ, lot 634162; Cat #SOP42HPKRD, lot 637131; Cat #SOP42KNKOD, lot 632967; Cat #SOP42MNKOM, lot 634092; Cat #SOP42PHOMK, lot 635492; Cat #SOP43ELLRB, lot 636119; Cat #SOP43KSLGF, lot 634293; Cat #SOP44HNSME, lot 634202; Cat #SOP44TKFSE, lot 633395; Cat #SOP44TKFSE, lot 635134; Cat #SOP45EXMKO, lot 634771; Cat #SOP45HNOCG, lot 634160; Cat #SOP45HPMVA, lot 635373; Cat #SOP48ACKAD, lot 633536; Cat #SOP48HPFAF, lot 634125; Cat #SOP48THLAA, lot 633072; Cat #SOP4AARNWC, lot 634726; Cat #SOP4AHASI1, lot 7545; Cat #SOP51ATSSC, lot 986838; Cat #SOP51EXDVG, lot 636019; Cat #SOP51LEMOG, lot 637145; Cat #SOP51XRKKB, lot 635228; Cat #SOP52FT73C, lot 634208; Cat #SOP53ARLEK, lot 634333; Cat #SOP53ETFOL, lot 635677; Cat #SOP53EXDCC, lot 635387; Cat #SOP53KNCCE, lots 633311 and 634813; Cat #SOP53KNSLC, lot 634179; Cat #SOP53MHPRI, lot 635312;  Cat #SOP53PPFRC, lot 637803; Cat #SOP54HDTCD, lot 634122; Cat #SOP54KAPRA, lot 987014; Cat #SOP55BCOKA, lot 633825; Cat #SOP56FTFOA, lot 985222; Cat #SOP56KN19R, lot 635155; Cat #SOP56KNSAQ, lot 636191; Cat #SOP56TKDCY, lot 634930; Cat #SOP57KNWGI, lot 633763; Cat #SOP59LXCPM, lot 634192; Cat #SOP59MNCHX, lot 637045; Cat #SOP5CAPGSC, lot 635171; Cat #SOP63KNSCL, lot 634454; Cat #SOP69AKPSB, lot 634161; Cat #SOP69FPEBB, lot 635340; Cat #SOP69OLFCC, lot 635445; Cat #SOP6NHDOIC, lot 986830; Cat #SOP73EXFSC, lot 636681; Cat #SOP73LOBDA, lot 635147; Cat #SOP73LXTCK, lot 634327;  Cat #SOP73TKSJB, lot 634055; Cat #SOP7CEMBRD, lot 8822; Cat #SOP92ONSID, lot 634481; Cat #SOPBOKANFE, lot 636064; Cat #SOPCGCTAUA, lot 987152; Cat #SOPCGHNWMC, lot 985228; Cat #SOPCGKAAUA, lot 987068; Cat #SOPCGTKAUB, lot 987207; Cat #SOPHBKNBIC, lot 9719; Cat #SOPHDEXRVB, lot 636398; Cat #SOPOCACPAB, lot 9760; Cat #SOPOCBOMSA, lot 10558; Cat #SPP99HD1AA, lot 636774 and 633896; Cat #SPP99KA2AA, lot 636315; Cat #SPP99PD1AA, lot 635104; Cat #SPP99TN1AA, lot 636786; Cat #SPP99TN3AA, lot 636027; Cat #SRH32STFGA, lot 635101; Cat #SRH73ACLSB, lot 635369; Cat #SRH73EXCCA, lot 986309; Cat #SRH73EXLSB, lot 635099; Cat #SRIOR0715Z, lot 9883; Cat #SUT69FBCPO, lot 633481;
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; Packaged by Cardinal Health Medical Products and services, McGaw Park, IL 60085 U.S.A.; There is no label on the Esmark bandage in the Presource pack/module, Some are placed in Tyvek pouches and some are just loose in the pack, but neither have any labeling on them. || The Esmark bandage is used to support and compress a part of the patient's body. Presource Packs/Modules are manufactured, according to customer requirements, for use during surgical procedures.
  • Manufacturer
    Cardinal Health
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