Events

Rappel de HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).

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 Philips Ultrasound, 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
    30160
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0178-05
  • Date de mise en oeuvre de l'événement
    2004-09-10
  • Date de publication de l'événement
    2004-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-02-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35287
  • 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
    System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
  • Cause
    Potential for device to cause burning of the skin.
  • Action
    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).
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • Adresse du fabricant
    Philips Ultrasound, Inc., 22100 Bothell-Everett Hwy., P.O. Box 3003, Bothell WA 98041-3003
  • Source
    USFDA