Events

Retiro De Equipo (Recall) de HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).

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 Ultrasound, 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
    30160
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0178-05
  • Fecha de inicio del evento
    2004-09-10
  • Fecha de publicación del evento
    2004-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35287
  • 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, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
  • Causa
    Potential for device to cause burning of the skin.
  • Acción
    On 9/6/04 the firm sent a certified return receipt letter to customers advising of the issue and informing that a service representative will visit to install new software to reduce thermal output.

Device

HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
  • Modelo / Serial
    Part # 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)  Site numbers: A42000896, A3B000796, A34000603, A2C000441, A32000483, A33000540, A28000273, A35000637, A35000649, A26000159, A45001061, A28000241, A37000732, A25000143, A35000663, A42000932, A32000505, A42000898, A33000546, A24000084, A26000165, A28000255, A28000266, A28000276, A45001050, A36000692, A45001066, A34000559, A24000052, A32000501, A2C000460, A3C000853, A34000582, A2A000350, A2C000458, A2B000408, A28000277, A27000197, A25000136, A33000550, A34000596, A24000104, A34000621, A33000549, A2B000374, A34000607, A43001003, A28000238, A34000568, A28000275, A36000674, A29000323, A2A000354, A29000318, A29000325, A27000188, A36000678, A28000253, A34000628, A27000204, A3B000804, A36000687, A3C000825, A25000140, A3B000799, A28000267, A2A000335, A2A000353, A31000489, A29000289, A2A000338, A39000780, A26000153, A35000636, A2A000348, A38000760, A42000916, A2B000395, A42000912, A24000101, A36000706, A35000665, A34000629, A42000907, A43001005, A25000131, A27000189, A25000123, A42000889, A2C000438, A2B000420, A28000231, A26000160, A37000735, A32000502, A34000595, A24000067, A42000885, A28000270, A24000054, A2B000358, A39000776, A2C000448, A3C000846, A24000087, A35000659, A2C000455, A39000769, A43001006, A26000161, A24000057, A42000945, A34000589, A37000723, A31000477, A31000488, A2B000411, A2C000440, A2C000452, A2C000456, A31000466, A31000467, A31000479, A31000480, A31000481, A32000509, A26000154, A27000181, A42000925, A33000523, A34000577, A3C000812, A29000290, A31000474, A34000602, A26000157, A2A000349, A42000901, A42000947, A23000047, A36000702, A25000146, A2A000345, A44001022, A28000280, A2C000449, A3C000850, A41000861, A24000060, A2A000330, A42000895, A27000212, A26000170, A27000192, A42000931, A37000738, A26000173, A26000179, A26000178, A29000300, A38000753, A39000783, A24000061, A2A000327, A27000186, A2C000463, A31000478, A2C000446, A31000492, A28000235, A28000229, A25000144, A2B000399, A27000198, A27000202, A2C000445, A34000588, A36000677, A3C000824, A43000982, A2B000365, A36000707, EMO00005, A36000705, 34000623, A26000176, A26000180, A25000106, A25000108, A25000115, A34000565, A34000578, A31000476, A32000504, A36000670, A2B000385, A3B000794, A2A000344, A36000694, A3B000806, A3C000826, A39000767, A42000899, A2C000437, A21000016, A25000118, A2C000444, A38000756, A37000720, A45001058, A37000721, A34000612, A32000490, A28000226, A28000260, A24000077, A25000111, A31000475, A33000534, A24000076, A25000116, A35000652, A31000470, A36000716, A35000630, A44001032, A41000872, A2C000451, A2C000457, A32000498, A29000319, A27000210, A24000051, A31000468, A34000557, A34000567, A3B000802, A42000934, A42000921, A35000650, A27000203, A23000040, A34000563, A21000018, A32000495, A36000717, A39000778, A24000096, A25000126, A26000164, A27000194, A42000893, A42000903, A32000515, A34000615, A34000616, A2C000439, A33000536, A34000587, A34000606, A32000507, A25000137, A24000056, A34000614, A25000133, A44001045, A25000147, A23000042, A35000664, A25000130, A25000148, A32000516, A34000611, A43000995, A37000736, A42000894, A31000482, A2A000331, A32000499, A43000980, A35000654, A44001019, A25000110, A34000556, A35000641, A35000642, A44001027, A44001028, A42000913, A3C000813, A42000928, A45001051, A2B000381, A2B000372, A2C000450, A32000513, A24000073, A3B000790, A34000597, A25000145, A31000493, A28000220, A34000627, A35000669, A28000265, A37000743, A35000645, A27000200, A29000310, A28000247, A26000171, A42000922, A27000184, A34000560, A28000243, A24000055, A35000644, A29000292, A21000015, A33000528, A32000517, A27000211, A28000257, A28000230, A2A000340, A34000599, A28000262, A2C000443, A2C000465, A35000643, A2A000337, A28000250, A31000491
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Units were distributed to medial facilities, hospitals, and veterinarians worldwide. Countries include Africa, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Domican Republic, Ecuador, France, Germany, Greece, Guam, Guatemala, Hungary, India, Israel, Italy, Jordan, Kuwait, Martinique, Mexico, Netherlands, New Zealand, Norway, Phlippines, Portugal, Puerto Rico, Peru, Santa Domingo, Saudia Arabia, Selangor, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Zenica
  • Descripción del producto
    HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • Dirección del fabricante
    Philips Ultrasound, Inc., 22100 Bothell-Everett Hwy., P.O. Box 3003, Bothell WA 98041-3003
  • Source
    USFDA