Events

Rappel de Device Recall IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA030102 and HA030002

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Iba Dosimetry Gmbh.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73036
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0683-2016
  • Date de mise en oeuvre de l'événement
    2015-12-10
  • Date de publication de l'événement
    2016-01-21
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142869
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Accelerator, linear, medical - Product Code IYE
  • Cause
    When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.
  • Action
    The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email on 12/10/2015 then followed by 12/17/2015 sent by Fed Ex. The firm requested the mains power be disconnected after setting up the table and BP. Replacement part and instructions will follow.

Device

Device Recall IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA030102 and HA030002
  • Modèle / numéro de série
    Serial numbers: 9204,9296,9297,9298,9299,9300,9445,9446,9447,9448,9596,9597,9598,9599,9600,9626,9627,9628,9629,9630,9631,9632,9633,9634,9635,9735,9736,9737,9738,9739,9744,9745,9746,9747,9748,9749,9750,9751,9752,9753,9754,9756,9838,9839,9840,9841,9842,9843,9844,9845,9846,9847,9848,9849,9850,9986,9987,9988,9989,9990,9991,10158,10159,10160,10184,10185,10186,10187, 10236,10237,10238,10239,10240,10241,10242,10243,10244,10245,10286, 10287,10288,10289,10304,10306,10307,10308,10309,10310,10312,10616, 10617,10618,10619,10635,10636,10663,10665,10666,10667,10668,10765, 10766,10839,10847,10848,10849,10850,10932,10936,10970,10972,10990, 10991,10992,10993,10994,10995,10996,10997,10998,10999,11000,11001, 11002,11003,11004,11005,11006,11007,11008,11009,11010,11011,11012, 11013,11014,11015,11016,11017,11018,11019,11020,11021,11022,11023, 11024,11025,11026,11027,11028,11029,11030,11031,11032,11033,11034, 11035,11036,11037,11038,11039,11540,11541,11542,11543,11544,11545, 11546,11547,11548,11549,11550,11551,11552,11553,11554,11555,11556, 11557,11558,11559,11560,11561,11562,11563,11564,11565,11566,11567, 11568,11569,12000,12001,12002,12003,12004,12005,12006,12007,12008, 12009,12010,12011,12012,12013,12014,12015,12016,12017,12018,12019, 12020,12021,12022,12023,12024,12025,12026,12027,12028,12029,12493, 12494,12495,12496,12497,12498,12499,12500,12501,12502,12503,12504, 12505,12506,12507,12508,12509,12510,12511,12512,12513,12514,12515, 12516,12517,12518,12519,12520,12521,12522,12892,12893,12894,12895, 12896,12897,12898,12899,12900,12901,12902,12903,12904,12905,12906, 12907,12908,12909,12910,12911,12912,12913,12914,12915,12916,12917, 12918,12919,12920,12921,12922,12923,12924,12925,12926,12927,12928, 12929,12930,12931,12932,12933,12934,12935,12936,12937,12938,12939, 12940,12941,13490,13491,13492,13493,13494,13495,13496,13497,13498, 13499,13500,13501,13502,13503,13504,13505,13506,13507,13508,13509, 13510,13511,13512,13513,13514,13515,13516,13517,13518,13519,13520, 13521,13522,13523,13524,13525,13526,13527,13528,13529,13530,13531, 13532,13533,13534,13535,13536,13537,13538,13539,14159,14160,14161, 14162,14163,14164,14165,14166,14167,14168,14169,14170,14171,14172, 14173,14174,14175,14176,14177,14178,14179,14180,14181,14182,14183, 14184,14185,14186,14187,14188,14189,14190,14191,14192,14193,14194, 14195,14196,14197,14198,14199,14200,14201,14202,14203,14204,14205, 14206,14207,14208,14970,14971,14972,14973,14974,14975,14976,14977, 14978,14979,14980,14981,14982,14983,14984,14985,14986,14987,14988, 14989,14990,14991,14992,14993,14994,14995,14996,14997,14998,14999, 15000,15001,15002,15003,15004,15005,15006,15007,15008,15009,15010, 15011,15012,15013,15014,15015,15016,15017,15018,15019,15585,15586, 15587,15588,15589,15590
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and International: Algeria, Angola, Arab Republic of Egypt, Austria, Belarus, Belgium, Bulgaria, Bosnia and Herzegovina, Croatia, Czech Republic, Denmark, Ethiopia, France, Germany, Ghana, Greece, Hungary, Iraq, Ireland, Islamic Republic Iran, Italy, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Libya, Morocco
  • Description du dispositif
    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
  • Manufacturer
    Iba Dosimetry Gmbh

Manufacturer

Iba Dosimetry Gmbh
  • Adresse du fabricant
    Iba Dosimetry Gmbh, Bahnhofstr. 5, Schwarzenbruck Germany
  • Société-mère du fabricant (2017)
    Ion Beam Applications SA
  • Source
    USFDA