Events

CosyCot 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fisher & Paykel Healthcare Ltd 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
    37003
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0485-2007
  • 사례 시작날짜
    2006-10-09
  • 사례 출판 날짜
    2007-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49741
  • 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
    Infant Radiant Warmer - Product Code FMT
  • 원인
    This firm has received product complaint reports concerning bending of the pivot plate. the elevator base of the cosycot infant warmer incorporates a pivot plate which forms part of the mechanism allowing the cosycot to raise and lower in height. a bent pivot plate generally results in the warmer being unable to elevate properly. other component failures may result.
  • 조치
    Fisher & Paykel Healthcare commenced sending out Product Correction Notifications letter via U.S. Postal Service certified mail October 9, 2006. This Product Correction Notice explained the nature of the problem and include a reminder of the maximum recommended weight of accessories. Two FAX Response Forms were provided, Part A for initial receipt of the Product Correction Notice and Part B for confirmation of the completed upgrade.

Device

CosyCot
  • 모델명 / 제조번호(시리얼번호)
    9893JEU00110,  9993JEU00004,  9993JEU00018,  9993JEU00019,  9993JEU00021,  9993JEU00081,  9993JEU00082,  9993JEU00083,  9993JEU00084,  9993JEU00139,  9993JEU00140,  9993JEU00150,  9993JEU00151,  9993JEU00204,  9993JEU00205,  9993JEU00332,  9993JEU00333,  9993JEU00424,  9993JEU00448,  9993JEU00449,  9993JEU00450,  9993JEU00494,  9993JEU00536,  9993JEU00537,  9993JEU00605,  9993JEU00606,  9993JEU00662,  9993JEU00663,  9993JEU00669,  9993JEU00670,  0093JEU00064,  0093JEU00065,  0093JEU00066,  0093JEU00067,  0093JEU00076,  0093JEU00077,  0093JEU00078,  0093JEU00079,  0093JEU00086,  0093JEU00087,  0093JEU00088,  0093JEU00131,  0093JEU00132,  0093JEU00133,  0093JEU00134,  0093JEU00200,  0093JEU00266,  0093JEU00305,  0093JEU00306,  0093JEU00307,  0093JEU00308,  0093JEU00309,  0093JEU00310,  0093JEU00345,  0093JEU00346,  2000-93JEU00402,  2000-93JEU00436,  2000-93JEU00437,  2000-93JEU00438,  2000-93JEU00439,  2000-93JEU00499,  2000-93JEU00500,  2000-93JEU00505,  2000-93JEU00506,  2000-93JEU00507,  2000-93JEU00508,  2000-93JEU00541,  2000-93JEU00602,  2000-93JEU00603,  2000-93JEU00604,  2000-93JEU00605,  2000-93JEU00606,  2000-93JEU00607,  2000-93JEU00608,  2000-93JEU00609,  2000-93JEU00610,  2001-93JEU00048,  2001-93JEU00059,  2001-93JEU00060,  2001-93JEU00061,  2001-93JEU00062,  2001-93JEU00063,  2001-93JEU00064,  2001-93JEU00277,  2001-93JEU00293,  2001-93JEU00294,  2001-93JEU00295,  2001-93JEU00304,  2001-93JEU00305,  2001-93JEU00306,  2001-93JEU00403,  2001-93JEU00404,  2001-93JEU00405,  2001-93JEU00406,  2001-93JEU00407,  2001-93JEU00408,  2001-93JEU00409,  2001-93JEU00435,  2001-93JEU00436,  2001-93JEU00437,  2001-93JEU00438,  2001-93JEU00439,  2001-93JEU00440,  2001-93JEU00441,  2001-93JEU00442,  2001-93JEU00443,  2001-93JEU00444,  2001-93JEU00445,  2001-93JEU00446,  2001-93JEU00447,  2001-93JEU00448,  2001-93JEU00449,  2001-93JEU00450,  2001-93JEU00451,  2001-93JEU00452,  010827000538,  010907000568,  011002000604,  011002000605,  011002000606,  011019000663,  011019000664,  011019000665,  011019000666,  011106000715,  011106000716,  011115000743,  011115000744,  011115000745,  011115000746,  011116000747,  011116000748,  011116000749,  011116000750,  011119000751,  011119000752,  011217000830,  011217000831,  011217000832,  011217000833,  011217000834,  020130000101,  020130000102,  020130000103,  020218000186,  020218000187,  020218000188,  020218000189,  020218000190,  020221000204,  020221000205,  020221000206,  020221000207,  020221000208,  020226000217,  020226000218, 020403000292, 020405000317, 020405000318, 20405000319, 20405000320, 020405000321, 020405000322 , 020510000390, 020510000391, 020510000392 , 020510000393, 020510000394, 020523000410, 020523000411, 020523000412, 020523000413, 020606000420, 020611000432, 020611000433, 020611000434, 020611000435, 020611000436, 020611000437, 20611000438, 020611000439, 020611000440, 020611000441, 020611000442, 020611000443, 020612000444, 020801000544, 020801000545, 020802000546, 020802000547, 020802000548, 020802000549, 020802000550, 020802000551, 020904000736, 020911000676, 020912000682, 020913000689, 020916000699, 020916000700, 020917000701, 020917000702, 020917000703, 020917000704, 020917000705, 020917000706, 020917000707, 020917000708, 020918000709, 020918000710, 020924000732, 020924000733, 020924000734, 020924000735, 021004000751, 021008000758, 021008000759, 021105000876, 021105000879, 021105000880, 021107000890, 021107000891, 021112000910, 021112000911, 021112000912, 030113000041, 030113000042, 030113000043, 030113000044, 030113000045, 030117000074, 030117000075, 030117000076, 030117000077, 030120000078, 030120000079, 030120000080, 030120000081, 030305000241, 030307000245, 030307000246, 030307000247, 030307000248, 030307000249, 030307000250, 030307000251, 030307000252, 030313000253, 030313000254, 030313000255, 030408000300, 030408000301, 030408000302, 030505000356, 030505000357, 030512000384, 030512000385, 030512000386, 030512000387, 030512000388, 030512000389, 030512000390, 030616000477, 030616000478, 030618000494, 030618000495, 030618000496, 030618000497, 030618000498, 030618000499, 030618000500, 030618000501, 030708000558, 030708000559, 30708000560, 30708000560, 030711000580, 030711000581, 030711000582, 030711000583, 030717000599, 030722000611, 030802000635, 030802000636, 030804000637, 030812000662, 030905000702, 030905000703, 030905000704, 030912000718, 030922000747, 031003000780, 031003000781, 031015000814, 031015000815, 031015000816, 031015000817, 031021000841, 031021000842, 031021000843, 031021000844, 031028000862, 031028000863, 031104000876, 031106000891, 031106000892, 031120000964, 031125001001, 031125001002, 031125001003, 031125001004, 031125001005, 031217001112, 040112000001, 040112000002, 040112000003, 040112000004, 040112000006, 040112000007, 040112000008, 040112000009, 040112000010, 040112000011, 040119000023, 040119000024, 040120000030, 040120000031, 040204000112, 040204000113 & 040204000114
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada
  • 제품 설명
    Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
  • Manufacturer
    Fisher & Paykel Healthcare Ltd

Manufacturer

Fisher & Paykel Healthcare Ltd
  • 제조사 주소
    Fisher & Paykel Healthcare Ltd, 15 Maurice Paykel Place, Auckland New Zealand
  • Source
    USFDA