Events

Rappel de Device Recall TCM4 series Base Unit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Radiometer America Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    65843
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1930-2013
  • Date de mise en oeuvre de l'événement
    2012-11-27
  • Date de publication de l'événement
    2013-08-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120458
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code LPP
  • Cause
    Radiometer became aware that the tcm4 series base unit does not comply with iec 60601-1 sub clause 15b.
  • Action
    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

Device Recall TCM4 series Base Unit
  • Modèle / numéro de série
    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, 391-878R0061N002-391-878R0061N016, 391-878R0061N022-391-878R0061N028, 391-878R0062N022-391-878R0062N024, 391-878R0062N029-391-878R0062N032, 391-878R007N014, 391-880 R0117N017, 391-8801R0059N007, 391-880L0027N012 391-880R0005N005, 391-880R0006N001-391-880R0006N009, 391-880R0006N012 391-880R0006N013, 391-880R0006N020, 391-880R0007N003-391-880R0007N011, 391-880R0007N018, 391-880R0008N001, 391-880R0008N007-391-880R0008N010, 391-880R0009N001-391-880R0009N003, 391-880R0009N002, 391-880R0009N003, 391-880R0009N012, 391-880R0009N014-391-880R0009N016, 391-880R0009N020, 391-880R0010N002-391-880R0010N009, 391-880R0010N014, 391-880R0010N015, 391-880R0010N017, 391-880R0010N020, 391-880R0011N003, 391-880R0011N004, 391-880R0011N020, 391-880R0012N001-391-880R0012N009, 391-880R0012N012, 391-880R0013N005-391-880R0013N010, 391-880R0013N012, 391-880R0013N013, 391-880R0013N015, 391-880R0013N016, 391-880R0015N004-391-880R0015N010, 391-880R0015N020, 391-880R0016N001, 391-880R0017N002-391-880R0017N004, 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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.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Adresse du fabricant
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA