Events

Retiro De Equipo (Recall) de Device Recall Philips Healthcare SureSigns VS2

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 Philips Healthcare 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
    64070
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0824-2013
  • Fecha de inicio del evento
    2013-01-14
  • Fecha de publicación del evento
    2013-02-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115317
  • 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
    System, measurement, blood-pressure, non-invasive - Product Code DXN
  • Causa
    Vs2+ screen may lock up and stop monitoring during patient use.
  • Acción
    Philips issued an Urgent Medical Device Correction letter on January 14, 2013. The field action will take place in two phases: Phase 1 Philips sent customer an Urgent Medical Device Correction Notification/Field Safety Notice. This notification explains the issues and gives the customers instructions on actions to take while they await the hardware correction. Phase 2 Once the hardware correction Philips will contact customers and perform the correction free of charge. Until the correction is available. Affected products may continue to be used while waiting for the correction from Philips if the unit is not used in NBP interval mode. A Philips Healthcare representative will contact you to arrange for the correction of all affected devices. If you need any further information or support concerning this issue, please contact the Philips Customer Care Center at 1-800-722-9377. On 3/14/13, firm stated Initially the fix would be a hardware upgrade but have since changed that to a software update. Customers within the US will be sent a new Field Safety Notice as well as a USB software update package and will be required to notify us upon the upgrade of their affected units. They will be performing the updates themselves

Device

Device Recall Philips Healthcare SureSigns VS2
  • Modelo / Serial
    Serial Numbers: CN14800428, CN14800429, CN14800430, CN14800431, CN14800432, CN14800433, CN14800434, CN14800435, CN14800436, CN14800437, CN14800438, CN14800439, CN14800440, CN14800756, CN14800763, CN14800764, CN14800765, CN14800772, CN14800773, CN14800822, CN14800823, CN14800824, CN14800979, CN14801332, CN21201423, CN21201625, CN21202029, CN21202030, CN21202031, CN21202032, CN21202033, CN21202034, CN21202234, CN21202239, CN21202240, CN21202241, CN21202242, CN21202243, CN21202317, CN21202320, CN21202347, CN21202348, CN21202349, CN21202350, CN21202351, CN21202376, CN21202435, CN21202606, CN21202607, CN21202862, CN21202863, CN21202883, CN21203006, CN21203007, CN21203008, CN21203009, CN21203010, CN21203073, CN21203180, CN21203304, CN21203307, CN21203308, CN21203309, CN21203310, CN21203311, CN21203312, CN21203707, CN21203781, CN21203794, CN21203795, CN21203796, CN21203797, CN21203949, CN21203950, CN21203951, CN21203952, CN21203953, CN21204204, CN21204205, CN21204206, CN21204207, 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CN21203538, CN21203539, CN21203540, CN21203541, CN21203542, CN21203543, CN21203544, CN21203545, CN21203546, CN21203547, CN21203548, CN21203549, CN21203550, CN21203551, CN21203552, CN21203553, CN21203554, CN21203555, CN21203556, CN21203557, CN21203558, CN21203559, CN21203560, CN21203561, CN21203562, CN21203563, CN21203564, CN21203565, CN21203566, CN21203567, CN21203568, CN21203569, CN21203570, CN21203571, CN21203572, CN21203573, CN21203574, CN21203575, CN21203576, CN21203577, CN21203578, CN21203579, CN21203580, CN21203581, CN21203582, CN21203583, CN21203584, CN21203585, CN21203586, CN21203587, CN21203588, CN21203589, CN21203590, CN21203591, CN21203592, CN21203593, CN21203594, CN21203595, CN21203596, CN21203597, CN21203598, CN21203599, CN21203600, CN21203601, CN21203602, CN21203603, CN21203604, CN21203605, CN21203606, CN21203607, CN21203608, CN21203609, CN21203610, CN21203611, CN21203612, CN21203613, CN21203614, CN21203615, CN21203616, CN21203619, CN21203620, CN21203621, CN21203622, CN21203623, CN21203624, CN21203625, CN21203640, CN21203641, CN21203642, CN21203643, CN21203644, CN21203645, CN21203646, CN21203647, CN21203648, CN21203649, CN21203650, CN21203651, CN21203652, CN21203653, CN21203654, CN21203655, CN21203656, CN21203657, CN21203658, CN21203659, CN21203660, CN21203661, CN21203662, CN21203663, CN21203664, CN21203665, CN21203666, CN21203667, CN21203668, CN21203669, CN21203670, CN21203671, CN21203672, CN21203673, CN21203674, CN21203675, CN21203676, CN21203677, CN21203678, CN21203679, CN21203680, CN21203681, CN21203682, CN21203683, CN21203684, CN21203685, CN21203686, CN21203687, CN21203688, CN21203689, CN21203690, CN21203691, CN21203692, CN21203693, CN21203694, CN21203695, CN21203696, CN21203697, CN21203698, CN21203699, CN21203700, CN21203701, CN21203704, CN21203705, CN21203715, CN21203716, CN21203717, CN21203718, CN21203719, CN21203720, CN21203721, CN21203722, CN21203723, CN21203724, CN21203732, CN21203733, CN21203734, CN21203735, CN21203742, CN21203743, CN21203780, CN21203828, CN21203839, CN21203840, CN21203841, CN21203842, CN21203843, CN21203844, CN21203845, CN21203846, CN21203847, CN21203848, CN21203849, CN21203850, CN21203851, CN21203852, CN21203853, CN21203854, CN21203855, CN21203856, CN21203857, CN21203858, CN21203859, CN21203860, CN21203861, CN21203862, CN21203863, CN21203864, CN21203865, CN21203866, CN21203867, CN21203868, CN21203869, CN21203886, CN21203926, CN21203927, CN21203928, CN21203938, CN21203939, CN21203940, CN21203941, CN21203942, CN21203943, CN21203944, CN21203945, CN21203967, CN21203968, CN21203969, CN21204005, CN21204013, CN21204029, CN21204030, CN21204031, CN21204032, CN21204033, CN21204034, CN21204035, CN21204036, CN21204037, CN21204038, CN21204039, CN21204040, CN21204041, CN21204049, CN21204050, CN21204051, CN21204052, CN21204053, CN21204054, CN21204055, CN21204056, CN21204057, CN21204058, CN21204059, CN21204060, CN21204061,  CN21204062, CN21204063, CN21204064, CN21204065, CN21204066, CN21204067, CN21204068, CN21204069, CN21204070, CN21204071, CN21204072, CN21204073, CN21204074, CN21204075, CN21204076, CN21204077, CN21204078, CN21204079, CN21204080, CN21204081, CN21204082, CN21204083, CN21204084, CN21204085, CN21204086, CN21204087, CN21204088, CN21204089, CN21204090, CN21204091, CN21204092, CN21204093, CN21204094, CN21204095, CN21204096, CN21204097, CN21204098, CN21204099, CN21204100, CN21204101, CN21204119, CN21204131, CN21204134, CN21204144, CN21204145, CN21204201, CN21204202, CN21204224, CN21204226, CN21204283, CN21204284, CN21204285, CN21204286, CN21204287, CN21204292, CN21204309, CN21204310, CN21204311, CN21204312, CN21204317, CN21204322, SP13701043, USPP101007, CN21201390, CN21201500, CN21201501, CN21201502, CN21201503, CN21201505, CN21201506, CN21201507, CN21201508, CN21201509, CN21201510, CN21201511, CN21201512, CN21201513, CN21201514, CN21201515, CN21201516, CN21201517, CN21201518, CN21201519, CN21201520, CN21201521, CN21201522, CN21201523, CN21201524, CN21201525, CN21201526, 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CN21203833, CN21203834, CN21203835, CN21203836, CN21203837, CN21203838, CN21203871, CN21203872, CN21203873, CN21203874, CN21203875, CN21203876, CN21203877, CN21203878, CN21203879, CN21203880, CN21203881, CN21203882, CN21203883, CN21203884, CN21203885, CN21203900, CN21203901, CN21203902, CN21203903, CN21203904, CN21203905, CN21203906, CN21203907, CN21203908, CN21203909, CN21203910, CN21203911, CN21203912, CN21203913, CN21203914, CN21203915, CN21203916, CN21203917, CN21203918, CN21203919, CN21203920, CN21203921, CN21203922, CN21203923, CN21203954, CN21203955, CN21203956, CN21203957, CN21203958, CN21203962, CN21203963, CN21203964, CN21203971, CN21203972, CN21203973, CN21203974, CN21203975, CN21203976, CN21203977, CN21203978, CN21203979, CN21203980, CN21203981, CN21203982, CN21203983, CN21203984, CN21203995, CN21203996, CN21203997, CN21203998, CN21204006, CN21204012, CN21204014, CN21204015, CN21204123, CN21204124, CN21204212, CN21204213, CN21204216, CN21204217, CN21204275, CN21204276, CN21204277, CN21204278, CN21204279, CN21204280, CN21204281, CN21204282, CN21204316, CN21204326, CN21204327, CN21204328, CN21204373, CN21204374, USPP3NCK10
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of: AUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE GERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA KUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND NORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES UNITED KINGDOM
  • Descripción del producto
    Philips Healthcare SureSigns VS2+ || Model 863278 SureSigns VS2+ NBP and SpO2 || Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature || Product Usage: || The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA