Retiro De Equipo (Recall) de HillRom 100 Low Bed

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 Hill-Rom, 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
    51389
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0338-2010
  • Fecha de inicio del evento
    2009-04-20
  • Fecha de publicación del evento
    2009-11-18
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2010-10-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    AC-powered adjustable hospital bed. - Product Code FNL
  • Causa
    The siderails may exhibit false latching, or unintentional lowering, or may become inoperable.
  • Acción
    Hill Rom notified consignees by recall letter dated 4/20/09 and advised them of the problem and requested them to locate the beds. Consignees with patients in need of siderails were directed to be moved to a different model bed with siderails and, if the patient did not need siderails; consignees were requested to remove the siderails, move the siderails to a stowed position, to tie the siderail to the bed frame or to tag the siderail as out of service. The letter stated the consignee would be contacted within 90 days by a firm representative to do a correction on all affected units.

Device

  • Modelo / Serial
    All units shipped prior to 3/6/09. Serial numbers  I331AR0046, I331AR0061, I331AR0062, I331AR0063, I333AR0088, I333AR0089, I333AR0090, I333AR0091, I333AR0092, I333AR0093, I333AR0094, I333AR0095, I334AR0096, I334AR0097, I334AR0098, I334AR0099, I334AR0100, I334AR0101, I334AR0102, I334AR0105, I334AR0106, I334AR0107, I334AR0108, I334AR0109, I334AR0110, I338AR0111, I338AR0112, I338AR0114, I338AR0115, I338AR0116, I338AR0118, I338AR0120, I338AR0121, I338AR0124, I338AR0125, I338AR0126, I339AR0148, I339AR0149, I339AR0150, I340AR0153, I340AR0155, I340AR0156, I340AR0157, I340AR0158, I340AR0159, I340AR0160, I340AR0161, I340AR0162, I340AR0163, I340AR0165, I340AR0166, I340AR0167, I340AR0168, I340AR0171, I348AR0177, I349AR0177, I349AR0179, I349AR0180, I349AR0181, I349AR0182, I349AR0183, I349AR0184, I349AR0185, I349AR0186, I349AR0187, I349AR0188, I349AR0189, I349AR0190, I349AR0191, I349AR0192, I349AR0193, I351AR0199, I351AR0200, I351AR0201, I351AR0202, I351AR0203, I351AR0204, I351AR0205, I351AR0206, I351AR0207, I351AR0208, I351AR0209, 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K099AR6538, K099AR6539, K099AR6540, K099AR6541, K099AR6543, K099AR6544, K110AR6545, K110AR6546, K110AR6547, K110AR6548, K110AR6549, K110AR6550, K110AR6551, K110AR6552, K110AR6553, K110AR6554, K110AR6555, K110AR6556, K110AR6557, K110AR6561, K110AR6562, K110AR6563, K111AR6564, K111AR6565, K111AR6566, K111AR6567, K111AR6568, K111AR6569, K111AR6570, K111AR6571, K111AR6572, K111AR6573, K111AR6574, K111AR6575, K111AR6576, K111AR6577, K111AR6578, K111AR6579, K112AR6580, K112AR6581, K112AR6582, K112AR6583, K112AR6584, K112AR6585, K112AR6586, K112AR6587, K112AR6588, K112AR6589, K112AR6590, K112AR6591, K112AR6592, K112AR6593, K112AR6594, K112AR6595, K113AR6596, K113AR6597, K113AR6598, K113AR6599, K113AR6600, K113AR6601, K113AR6602, K113AR6603, K113AR6604, K113AR6605, K113AR6606, K113AR6607, K113AR6608, K113AR6609, K114AR6610, K114AR6611, K114AR6612, K114AR6613, K114AR6614, K114AR6615, K114AR6616, K114AR6617, K114AR6618, K114AR6619, K114AR6620, K114AR6621, K114AR6622, K114AR6623, K114AR6624, 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K138AR6817, K138AR6818, K139AR6819, K139AR6820, K139AR6821, K139AR6822, K139AR6823, K139AR6826, K139AR6827, K139AR6828, K139AR6829, K139AR6830, K139AR6831, K139AR6832, K139AR6833, K139AR6834, K139AR6835, K139AR6836, K139AR6837, K139AR6838, K139AR6839, K139AR6840, K139AR6841, K139AR6842, K139AR6843, K139AR6844, K139AR6845, K139AR6846, K140AR6847, K140AR6848, K140AR6849, K169AR6891, K169AR6892 and K169AR6893.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Canada, France, India, Singapore and Spain.
  • Descripción del producto
    Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA