Events

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

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Iba Dosimetry Gmbh 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    73036
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0683-2016
  • 사례 시작날짜
    2015-12-10
  • 사례 출판 날짜
    2016-01-21
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142869
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Accelerator, linear, medical - Product Code IYE
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
  • Manufacturer
    Iba Dosimetry Gmbh

Manufacturer

Iba Dosimetry Gmbh
  • 제조사 주소
    Iba Dosimetry Gmbh, Bahnhofstr. 5, Schwarzenbruck Germany
  • 제조사 모회사 (2017)
    Ion Beam Applications SA
  • Source
    USFDA