Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Iba Dosimetry Gmbh.

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
    73036
  • Event Risk Class
    Class 2
  • Event Number
    Z-0683-2016
  • Event Initiated Date
    2015-12-10
  • Event Date Posted
    2016-01-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142869
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
  • Manufacturer
    Iba Dosimetry Gmbh

Manufacturer

Iba Dosimetry Gmbh
  • Manufacturer Address
    Iba Dosimetry Gmbh, Bahnhofstr. 5, Schwarzenbruck Germany
  • Manufacturer Parent Company (2017)
    Ion Beam Applications SA
  • Source
    USFDA