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U.S. Department of Health and Human Services

Class 2 Device Recall IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA030102 and HA030002

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  Class 2 Device Recall IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA030102 and HA030002 see related information
Date Initiated by Firm December 10, 2015
Date Posted January 21, 2016
Recall Status1 Terminated 3 on August 08, 2018
Recall Number Z-0683-2016
Recall Event ID 73036
510(K)Number K945321  
Product Classification Accelerator, linear, medical - Product Code IYE
Product IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Code Information 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 
Recalling Firm/
Manufacturer		 Iba Dosimetry Gmbh
Bahnhofstr. 5
Schwarzenbruck Germany
For Additional Information Contact W. Michael Meyer
901-386-2242
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Component design/selection
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.
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = MEDICAL PHYSICS INSTRUMENTATION, INC.
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