Z-0683-2016Class II
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
IBA Dosimetry GmbH / initiated 2015-12-10 / Terminated / root cause: design
Iba Dosimetry Gmbh began a recall of IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0683-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- IBA Dosimetry GmbH
- Product
- IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
- Product code
- IYE Accelerator, Linear, Medical
- 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.
- Root cause tag
- design
- FDA root cause
- 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
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0683-2016 | Class II | Terminated | Voluntary: Firm initiated |
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