Device Recall TCM4 series Base Unit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Radiometer America Inc 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
    65843
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1930-2013
  • 사례 시작날짜
    2012-11-27
  • 사례 출판 날짜
    2013-08-08
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-06-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code LPP
  • 원인
    Radiometer became aware that the tcm4 series base unit does not comply with iec 60601-1 sub clause 15b.
  • 조치
    On 11/30/2012 the firm sent an "Urgent Field Safety Notice" to their customers. The notification explained the issue and provided recommended actions. Customers may contact 1-800-736-0600 option 4 with questions.

Device

  • 모델명 / 제조번호(시리얼번호)
    TCM4 series Base Units: 000-154, 391-876, 391-878 and 391-880 below R0175N009 & Power Supply (Spare part): 910-246. Serial #: 154R0002N002, 154R0004N003, 154R0004N008, 154R0005N004, 154R0005N005, 154R0005N005-U, 154R0005N006-154R0005N006, 154R0006N005, 154R0006N006, 154R0006N008-154R0006N010, 154R0007N001-154R0007N010, 154R0008N001, 154R0008N002, 154R0008N002U, 154R0008N003, 154R0008N005-154R0008N010, 154R0009N004, 154R0009N010, 154R0011N003, 154R0011N006-154R0011N009, 154R0012N001-154R0012N003, 154R0013N004, 154R0013N005, 154R0013N007-154R0013N010, 154R0014N009, 154R0016N001-154R0016N003, 154R0016N008, 154R0016N009, 154R0016N010, 154R0017N007, 154R0019N001-154R0019N005, 154R0019N007, 154R0019N009, 154R0019N010, 154R0020N002, 154R0021N003, 154R0021N004U, 154R0021N005, 154R0021N008, 154R0021N010, 154R0022N008-154R0022N010, 154R0023N006, 154R0023N007, 154R0023N009, 154R0023N010, 154R0024N004-154R0024N006, 154R0024N009, 154R0024N010, 154R0025N002, 154R0025N004-154R0025N006, 154R0026N008, 154R0027N001-154R0027N005, 154R0027N007, 154R0028N001-154R0028N004, 154R0028N006-154R0028N006, 154R0029N003-154R0029N007, 154R0029N009, 154R0030N001, 154R0030N004-, 54R0030N007, 154R0030N008U, 154R0031N001, 154R0031N003-154R0031N009, 154R0034N006, 154R0034N008, 154R0034N009, 154R0035N002, 154R0035N003, 154R0035N006, 154R0035N008, 154R0035N009, 154R0035N010, 154R0036N010, 154R0036N002-154R0036N009, 154R0038N002-154R0038N006, 154R0040N001, 154R0040N002, 154R0040N009, 154R0040N010, 154R0041N001, 154R0041N003, 154R0041N004, 154R0041N006-154R0041N008, 154R0042N001, 154R0042N002, 154R0042N004, 154R0042N005, 154R0046N002, 154R0046N004, 154R0046N006-154R0046N008, 154R0047N002, 154R0048N002-154R0048N004, 154R0048N007, 154R0050N001-154R0050N009, 154R0051N001, 154R0051N003-154R0051N003, 154R0052N001-154R0052N009, 154R0053N007-154R0053N010, 154R0054N001, 154R0054N002, 154R0054N004, 154R0055N002-154R0055N006, 154R0056N001, 154R0056N002, 154R0056N005, 154R0056N006, 154R0056N008-154R0056N010, 154R0057N001-154R0057N004, 154R0057N008, 154R0057N009, 154R0058N001-154R0058N003, 154R0059N002-154R0059N004, 154R0059N006-154R0059N008 154R005N001, 154R0060N007-154R0060N009, 154R006N003, 154R0071N014, 154R031N010, 154R039N005, 154R039N006, 28N012, 28N013, 32N002, 381-880R0008N005 391-876R0001N003, 391-876R0001N006, 391-876R0001N007, 391-876R0001N010, 391-876R0002N004, 391-876R0002N009, 391-876R0003N001, 391-876R0003N004-391-876R0003N006, 391-876R0003N008, 391-876R0003N009, 391-876R0004N002, 391-876R0004N002U, 391-876R0004N009, 391-876R0004N014, 391-876R0005N003, 391-876R0005N004, 391-876R0006N011, 391-876R0007N007, 391-876R0007N008, 391-876R0007N010, 391-876R0011N001, 391-876R0011N002, 391-876R0011N009, 391-876R0011N010, 391-876R0012N002, 391-876R0012N002U, 391-876R0012N007, 391-876R0012N008, 391-876R0012N010, 391-876R0014N002, 391-876R0014N003, 391-876R0014N005, 391-876R0014N006, 391-876R0016N007, 391-876R0016N010, 391-876R0016N010U, 391-876R0017N002, 391-876R0018N004-391-876R0018N009, 391-876R0019N001, 391-876R0019N008-391-876R0019N010, 391-876R0020N001, 391-876R0022N002-391-876R0022N008, 391-876R0022N009-U, 391-876R0023N001, 391-876R0023N006, 391-876R0023N009, 391-876R0024N001-391-876R0024N003, 391-876R0024N005, 391-876R0024N006, 391-876R0026N001, 391-876R0026N002, 391-876R0026N005, 391-876R0026N006, 391-876R0027N007, 391-876R0027N008, 391-876R0028N002, 391-876R0028N018-391-876R0028N020, 391-876R0029N005, 391-876R0029N007, 391-876R0029N009, 391-876R0029N012, 391-876R0029N019, 391-876R0030N001, 391-876R0030N002, 391-876R0030N006-391-876R0030N008, 391-876R0031N009, 391-876R0031N011, 391-876R0031N012, 391-876R0031N013, 391-876R0031N016, 391-876R0031N020, 391-876R0032N020, 391-876R0032N018, 391-876R0033N003, 391-876R0033N005, 391-876R0034N004, 391-876R0034N004U, 391-876R0034N006, 391-876R0034N007, 391-876R0034N009, 391-876R0034N010, 391-876R0034N017, 391-876R0034N018, 391-876R0035N005, 391-876R0035N006, 391-876R0035N007U, 391-876R0035N008, 391-876R0035N017, 391-876R0036N001, 391-876R0036N003, 391-876R0036N004, 391-876R0036N007, 391-876R0036N008, 391-876R0036N010, 391-876R0036N011, 391-876R0036N013, 391-876R0036N016, 391-876R0037N010, 391-876R0037N012, 391-876R0037N013, 391-876R0038N003, 391-876R0038N017, 391-876R0039N003, 391-876R0039N004, 391-876R0039N006, 391-876R0039N008, 391-876R0039N009, 391-876R0039N011, 391-876R0039N012, 391-876R0040N001, 391-876R0040N001U, 391-876R0040N015, 391-876R0040N018, 391-876R0040N019, 391-876R0041N003, 391-876R0041N004, 391-876R0041N005, 391-876R0041N011U, 391-876R0041N012-391-876R0041N016, 391-876R0042N001, 391-876R0042N005-391-876R0042N012, 391-876R0042N015, 391-876R0042N020, 391-876R0043N001, 391-876R0043N002, 391-876R0043N004-391-876R0043N009, 391-876R0043N014, 391-878R0002N001, 391-878R0002N002, 391-878R0002N004-391-878R0002N006, 391-878R0004N008, 391-878R0004N009, 391-878R0004N013-391-878R0004N015, 391-878R0004N018-391-878R0004N020, 391-878R0005N001, 391-878R0005N002, 391-878R0005N011-391-878R0005N013, 391-878R0005N015, 391-878R0005N020, 391-878R0006N003, 391-878R0006N010-391-878R0006N013, 391-878R0007N004-391-878R0007N010, 391-878R0007N015, 391-878R0008N005-391-878R0008N007, 391-878R0008N009, 391-878R0008N012, 391-878R0008N014-391-878R0008N020, 391-878R0009N004, 391-878R0009N011-391-878R0009N014, 391-878R0009N018, 391-878R0009N019, 391-878R0009N020, 391-878R0010N001, 391-878R0010N005-391-878R0010N010, 391-878R0010N015-391-878R0010N017, 391-878R0011N002-391-878R0011N006, 391-878R0011N009, 391-878R0011N011-391-878R0011N019, 391-878R0012N004, 391-878R0012N009, 391-878R0012N010, 391-878R0012N011, 391-878R0012N020, 391-878R0013N001-391-878R0013N004, 391-878R0013N008, 391-878R0013N011-391-878R0013N013, 391-878R0013N015-391-878R0013N020, 391-878R0014N001-391-878R0014N011, 391-878R0014N013, 391-878R0015N019, 391-878R0015N020, 391-878R0016N001, 391-878R0016N008-391-878R0016N011, 391-878R0016N018, 391-878R0016N019, 391-878R0016N020, 391-878R0017N001-391-878R0017N005, 391-878R0017N008, 391-878R0017N010, 391-878R0017N014, 391-878R0018N004-391-878R0018N013, 391-878R0018N016, 391-878R0018N017, 391-878R0019N001-391-878R0019N004, 391-878R0019N006, 391-878R0019N020, 391-878R0020N001-391-878R0020N006, 391-878R0020N012-391-878R0020N016, 391-878R0020N018, 391-878R0020N019, 391-878R0021N009 391-878R0021N010, 391-878R0021N011, 391-878R0022N017, 391-878R0023N013, 391-878R0023N014, 391-878R0023N019, 391-878R0023N020, 391-878R0024N002, 391-878R0024N003, 391-878R0024N006, 391-878R0024N008, 391-878R0024N010, 391-878R0024N011, 391-878R0024N015, 391-878R0025N002, 391-878R0025N004-391-878R0025N014, 391-878R0026N003, 391-878R0026N004, 391-878R0026N006, 391-878R0027N008, 391-878R0027N015, 391-878R0027N017, 391-878R0027N018, 391-878R0027N020, 391-878R0028N002, 391-878R0028N003, 391-878R0028N005, 391-878R0028N007-391-878R0028N009, 391-878R0028N015-391-878R0028N017, 391-878R0028N020, 391-878R0029N002-391-878R0029N004, 391-878R0029N018, 391-878R0029N019, 391-878R0030N001, 391-878R0030N010, 391-878R0030N011, 391-878R0030N020, 391-878R0031N009-391-878R0031N011, 391-878R0031N013, 391-878R0031N015, 391-878R0031N016, 391-878R0032N001, 391-878R0032N003, 391-878R0032N010, 391-878R0032N014, 391-878R0032N015, 391-878R0032N016, 391-878R0032N020, 391-878R0033N001, 391-878R0033N008-391-878R0033N012, 391-878R0034N0013, 391-878R0034N006, 391-878R0034N007U, 391-878R0034N014-391-878R0034N020, 391-878R0035N001, 391-878R0035N006-391-878R0035N011, 391-878R0035N014, 391-878R0036N001-391-878R0036N004, 391-878R0036N010, 391-878R0036N012-391-878R0036N016, 391-878R0037N004-391-878R0037N008, 391-878R0037N010-391-878R0037N012, 391-878R0038N010-391-878R0038N013, 391-878R0038N019, 391-878R0038N020, 391-878R0039N001, 391-878R0039N009-391-878R0039N020, 391-878R0040N002-391-878R0040N005, 391-878R0040N014-391-878R0040N017, 391-878R0041N011-391-878R0041N014, 391-878R0042N007-391-878R0042N011, 391-878R0043N001, 391-878R0043N004, 391-878R0043N010, 391-878R0043N011, 391-878R0043N015-391-878R0043N018, 391-878R0044N011D, 391-878R0044N012-391-878R0044N019, 391-878R0045N001-391-878R0045N003, 391-878R0045N006, 391-878R0045N008, 391-878R0045N018-391-878R0045N020, 391-878R0046N001-391-878R0046N003, 391-878R0047N010, 391-878R0047N012-391-878R0047N015, 391-878R0047N018-391-878R0047N020, 391-878R0048N001-391-878R0048N012, 391-878R0049N002-391-878R0049N016, 391-878R0050N001-391-878R0050N005, 391-878R0050N007, 391-878R0050N008, 391-878R0050N012-391-878R0050N019, 391-878R0052N007, 391-878R0052N011-391-878R0052N020, 391-878R0053N003, 391-878R0053N007, 391-878R0053N009, 391-878R0053N011-391-878R0053N014, 391-878R0055N001, 391-878R0055N002, 391-878R0055N004, 391-878R0056N013-391-878R0056N015, 391-878R0057N011-391-878R0057N017, 391-878R0058N002, 391-878R0058N006, 391-878R0058N007, 391-878R0058N011, 391-878R0058N013, 391-878R0059N011, 391-878R0059N012, 391-878R0059N014-391-878R0059N019, 391-878R0060N001, 391-878R0060N007, 391-878R0060N008, 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391-880R0017N006-391-880R0017N010, 391-880R0017N013, 391-880R0017N017-391-880R0017N019, 391-880R0019N006-391-880R0019N008, 391-880R0019N010, 391-880R0019N011, 391-880R0019N012, 391-880R0020N016, 391-880R0020N017, 391-880R0020N019, 391-880R0020N020, 391-880R0021N001-391-880R0021N004, 391-880R0022N002-391-880R0022N005, 391-880R0024N002, 391-880R0024N003, 391-880R0024N005, 391-880R0024N006, 391-880R0025N003-391-880R0025N015, 391-880R0025N018, 391-880R0025N019, 391-880R0026N001-391-880R0026N004, 391-880R0026N002, 391-880R0026N003, 391-880R0026N004, 391-880R0026N013, 391-880R0026N015, 391-880R0026N017, 391-880R0026N018, 391-880R0027N001-391-880R0027N011, 391-880R0027N013, 391-880R0027N014, 391-880R0027N016, 391-880R0027N019, 391-880R0027N020, 391-880R0028N001-391-880R0028N006, 391-880R0029N001-391-880R0029N006, 391-880R0029N008, 391-880R0029N009, 391-880R0029N012-391-880R0029N016, 391-880R0030N009, 391-880R0030N011, 391-880R0030N013, 391-880R0030N014, 391-880R0031N013-391-880R0031N018, 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391-880R0082N020, 391-880R0083N001-391-880R0083N003, 391-880R0083N005-391-880R0083N010, 391-880R0083N017, 391-880R0083N020, 391-880R0084N001-391-880R0084N007, 391-880R0084N011-391-880R0084N013, 391-880R0087N017, 391-880R0088N001, 391-880R0089N007, 391-880R0089N010-391-880R0089N013, 391-880R0089N016, 391-880R0089N017, 391-880R0089N019, 391-880R0089N020, 391-880R0089R008, 391-880R0090N001, 391-880R0090N002, 391-880R0090N004-391-880R0090N020, 391-880R0091N001-391-880R0091N001, 391-880R0091N006, 391-880R0091N007, 391-880R0093N016, 391-880R0094N009, 391-880R0094N010, 391-880R0094N012-391-880R0094N014, 391-880R0094N020, 391-880R0097N005, 391-880R0097N009, 391-880R0098N012, 391-880R0100N012, 391-880R0100N016, 391-880R0100N020, 391-880R0101N002, 391-880R0101N004, 391-880R0101N005, 391-880R0101N007-391-880R0101N009, 391-880R0101N019, 391-880R0102N001, 391-880R0103N011-391-880R0103N013, 391-880R0103N017, 391-880R0104N018, 391-880R0105N011, 391-880R0106N003, 391-880R0106N012, 391-880R0106N013, 391-880R0106N016, 391-880R0106N017, 391-880R0107N004, 391-880R0107N005, 391-880R0107N008, 391-880R0109N007, 391-880R0112N004, 391-880R0112N006-391-880R0112N008, 391-880R0114N001, 391-880R0115N006-391-880R0115N009, 391-880R0115N011, 391-880R0115N019, 391-880R0115N020, 391-880R0116N001-391-880R0116N003, 391-880R0123N017, 391-880R0128N001-391-880R0128N004, 391-880R0162N007, 391-880R0165N006, 391-880R0165N007, 876R0004N003, 876R0004N004, 876R0004N009, 876R0005N002, 876R0005N005, 876R0008N002, 876R0014N006, 876R0016N003, 876R0016N006, 876R0017N001, 876R0018N010U, 876R0019N007, 876R0021N001, 876R0021N003, 876R0022N002, 876R0023N002, 876R0023N003, 876R0023N005, 876R0023N006, 876R0024N004, 876R0027N009, 876R0028N013U, 876R0029N001, 876R0029N0013, 876R0029N0016, 876R0029N003, 876R0029N004, 876R0029N006, 876R0029N008, 876R0029N009, 876R0029N014, 876R0029N018, 876R0029N020-5, 876R0030N003, 876R0030N009, 876R0030N010, 876R0031N001, 876R0031N004-876R0031N007, 876R0031N018, 876R0031N019, 876R0032N004-876R0032N007, 876R0033N004, 876R0033N006, 876R0033N017, 876R0033N018, 876R0034N003, 876R0034N005, 876R0034N006, 876R0034N019, 876R0035N015, 876R0035N016, 876R0036N017, 876R0036N018, 876R0038N003, 876R0039N007, 876R0040N003, 876R0041N002, 876R0042N016, 876R0042N017, 876R0042N018, 876R0042N019, 876R0043N006, 878R0009N005, 878R0010N002, 878R0010N004, 878R0010N018, 878R0015N002U, 878R0015N008U, 878R0017N012, 878R0017N013, 878R0018N016, 878R0022N016, 878R0023N012, 878R0026N005, 878R0028N011, 878R0028N019, 878R0031N012, 878R0036N005, 878R0040N0001, 878R0040N013, 878R0044N020, 878R0055N002U, 880R0009N013, 880R0010N017-880R0010N019, 880R00113N019, 880R0011N002, 880R0013N014, 880R0022N006, 880R0026N005, 880R0037N011, 880R0040N008, 880R0045N005U, 880R0066N009, 880R0083N015U, 880R0083N019, 880R0095N013, 880R0097N010, 880R0106N014, 880R0106N015, 880R0107N001-880R0107N003, 880R0107N006, 880R0107N007, 880R0109N003-880R0109N006, 880R0109N008, 880R0111N004-880R0111N006, 880R0111N009, 880R0111N012-880R0111N015, 880R0111N017-880R0111N020, 880R0112N001, 880R0112N005, 880R0112N010, 880R0112N011, 880R0113N018, 880R0113N020, 880R0114N010-880R0114N017, 880R0114N020, 880R0115N001-880R0115N003, 880R0115N010, 880R0117N016, 880R0117N017, 880R0118N003, 880R0118N005-880R0118N009, 880R0118N013, 880R0118N014, 880R0118N017-880R0118N020, 880R0119N001-880R0119N013, 880R0120N015, 880R0121N002, 880R0121N003, 880R0121N005-880R121N011, 880R0121N013-880R0121N020, 880R0122N001, 880R0123N011-880R0123N015, 880R0124N020, 880R0125N001-880R0125N004, 880R0126N019, 880R0126N020, 880R0127N001-880R0127N008, 880R0127N010-880R0127N020, 880R0131N017-880R0131N020, 880R0132N001-880R0132N006, 880R0132N020, 880R0133N001-880R0133N013, 880R0133N017-880R0133N020, 880R0135N018-880R0135N020, 880R0136N001-880R0136N007, 880R0136N010-880R0136N020, 880R0137N001-880R0197N007, 880R0140N019, 880R0140N020, 880R0141N001-880R0141N015, 880R0141N019, 880R0142N001-880R0142N010, 880R0145N009-880R0145N017, 880R0146N011-880R0146N018, 880R0151N001, 880R0151N005-880R0151N008, 880R0151N016-880R0151N020, 880R0153N008, 880R0153N009, 880R0153N015-880R0153N017, 880R0154N014-880R0154N020, 880R0155N001-880R0155N003, 880R0155N012-880R0155N019, 880R0156N002, 880R0156N003, 880R0156N006, 880R0156N008, 880R0156N009, 880R0156N010, 880R0156N013, 880R0156N015, 880R0156N017, 880R0156N019, 880R0157N007, 880R0157N009, 880R0158N006, 880R0158N007, 880R0158N010, 880R0158N011, 880R0158N012, 880R0158N013, 880R0158N017, 880R0159N001, 880R0159N002, 880R0159N003, 880R0159N009, 880R0159N010-880R0159N019, 880R0161N014-880R0161N020, 880R0162N001-880R0162N005, 880R0165N008, 880R0165N009, 880R0165N010, 880R0167N003-880R0167N010, 880R0167N015, 880R0167N019, 880R0170N008, 880R0170N009, 880R0170N011, 880R0171N019, 880R0171N020, 880R0172N001, 880R0172N002, 880R0172N005, 880R0177N009, 880R0177N010, 880R0177N012, 880R0177N013, 880R0177N014, 880R0178N013, 880R0178N014, 880R0178N015, 880R0178N017-880R0178N020, 880R9999N999, 888R0178N016, R0011N002, R0014N012, R0016N008, R0027B009, R0027N009, R0030N007, R0041N001, R0048N005, R035N001 & TCMXX 00000154R00.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, WV & WY; and country of: Canada.
  • 제품 설명
    TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • 제조사 모회사 (2017)
  • Source
    USFDA