Events

Retiro De Equipo (Recall) de Device Recall TCM4 series Base Unit

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Radiometer America Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    65843
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1930-2013
  • Fecha de inicio del evento
    2012-11-27
  • Fecha de publicación del evento
    2013-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120458
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code LPP
  • Causa
    Radiometer became aware that the tcm4 series base unit does not comply with iec 60601-1 sub clause 15b.
  • Acción
    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
  • Modelo / Serial
    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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391-880R0106N016, 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.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA