Events

Retiro De Equipo (Recall) de EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option

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
    71105
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1631-2015
  • Fecha de inicio del evento
    2015-04-14
  • Fecha de publicación del evento
    2015-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136135
  • 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
    When epiq 5 ultrasound system, without the pediatric cardiology option, is set up to "metric" and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of the patients body surface area (bsa).
  • Acción
    Philips sent the Urgent-Medical Device Correction-Philips Model EPIQ5 Ultrasound system and the Urgent-Medical Device Correction-Philips Model EPIQ7 Ultrasound system letters, both dated 2015 APR 14, to their US consignees. Philips sent the Urgent-Field Safety Notice-Philips Model EPIQ5 Ultrasound system letter and the Urgent-Field Safety Notice-Philips Model EPIQ7 Ultrasound system letter (both letters dated 2015 APRIL 14) to their foreign consignees. The EPIQ5 or EPIQ7 Ultrasound systems WITHOUT the Pediatric Cardiology option are affected. Philips issued two Field Change Orders (FCO) to their Field Service Engineer to install upgraded software: -FCO 79500340 for EPIQ5 -FCO 79500341 for EPIQ7 Customers with questions can call Philips Customer Service at 1-800-722-9377. Field Service Engineers (FSE) to install software version 1.3.3 per FCO 79500340 instructions for EPIQ5 5 and per FCO 79500341 instructions for EPIQ7.

Device

EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option
  • Modelo / Serial
    ********************SYSTEM BASE ID IN THE US*****************************  US114C0207, US114C0208, US114C0209, US114C0287, US114C0308, US114C0323, US114C0330, US114C0445, US114C0713, US114C0714, US114C0731, US115C0139, US115C0464, US115C0465, US115C0470, US115C0471, US115C0537, US115C0538, US115C0539, US115C0576, US115C0607, US214C0042, US214C0084, US214C0103, US214C0104, US214C0105, US214C0141, US214C0142, US214C0162, US214C0180, US214C0434, US215C0068, US215C0069, US215C0070, US215C0072, US215C0073, US215C0074, US215C0171, US215C0172, US215C0178, US215C0179, US215C0180, US215C0306, US215C0307, US215C0308, US215C0406, US215C0407, US215C0449, US215C0450, US215C0512, US215C0513, US215C0514, US215C0516, US215C0534, US215C0535, US215C0538, US215C0539, US215C0571, US215C0572, US215C0573, US215C0615, US215C0616, US215C0617, US215C0618, US215C0619, US215C0620, US215C0624, US215C0625, US215C0626, US215C0627, US215C0713, US215C0714, US215C0715, US215C0716, US215C0717, US215C0769, 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USD14C0757, USD14C0762, USD14C0763, USD14C0764, USD14C0765, USD14C0877, USD14C0878, USD14C0879, USD14C0880, USD14C0881, USD14C0882, USD14C0883, USD14C0884, USD14C0885, USD14C0965, USD14C0966, USD14C0967, USD14C0968, USD14C0969, USD14C0970, USD14C0971, USD14C1019, USD14C1020, USD14C1021, USD14C1022, USD14C1023, USD14C1041, USD14C1042, USD14C1043, USN13C0341, USN13C0342, USN13C0394, USN13C0395, USN13C0396, USN13C0458, USN13C0463, USN13C0576, USN13C0577, USN13C0578, USN14C0032, USN14C0033, USN14C0034, USN14C0035, USN14C0036, USN14C0039, USN14C0103, USN14C0185, USN14C0186, USN14C0240, USN14C0366, USN14C0367, USN14C0380, USN14C0408, USN14C0418, USN14C0442, USN14C0464, USN14C0467, USN14C0468, USN14C0471, USN14C0472, USN14C0535, USN14C0536, USN14C0696, USN14C0697, USN14C0779, USN14C0886, USN14C0887, USN14C0943, USN14C0944, USN14C0945, USO13C0118, USO13C0119, USO13C0120, USO13C0346, USO13C0347, USO13C0348, USO13C0349, USO13C0351, USO13C0355, USO13C0356, USO13C0357, USO13C0380, USO13C0419, USO13C0458, USO13C0474, USO13C0475, USO13C0476, USO13C0477, USO13C0478, USO13C0479, USO13C0480, USO13C0481, USO13C0484, USO13C0485, USO13C0513, USO13C0514, USO13C0515, USO13C0516, USO13C0526, USO13C0527, USO13C0528, USO13C0529, USO13C0530, USO13C0531, USO13C0532, USO13C0533, USO13C0534, USO13C0535, USO13C0536, USO13C0537, USO13C0538, USO13C0539, USO13C0552, USO13C0575, USO13C0576, USO13C0577, USO13C0578, USO13C0579, USO13C0580, USO13C0581, USO13C0582, USO13C0583, USO13C0584, USO13C0585, USO13C0586, USO13C0587, USO13C0588, USO13C0613, USO14C0034, USO14C0054, USO14C0055, USO14C0081, USO14C0095, USO14C0097, USO14C0166, USO14C0278, USO14C0279, USO14C0280, USO14C0281, USO14C0282, USO14C0340, USO14C0377, USO14C0378, USO14C0380, USO14C0480, USO14C0481, USO14C0517, USO14C0570, USO14C0609, USO14C0610, USO14C0660, USO14C0662, USO14C0663, USO14C0664, USO14C0665, USO14C0666, USO14C0805, USO14C0806, USO14C0807, USO14C0808, USO14C0846, USO14C1090, USO14C1092, USO14C1117, and USO14C1118.    *********************SYSTEM BASE ID IN CANANA****************************  US115C0433, US115C0495, US115C0496, US115C0497, US115C0498, US115C0499, US115C0571, US215C0348, US215C0566, US215C0567, US215C0679, US215C1042, US315C0090, US315C0404, US315C0405, US315C0406, US414C0604, US714C0076, US714C0297, US814C0111, US914C0200, USD14C0156, USN14C0382, USN14C0383, USN14C0384, USO14C0511, USO14C0512, and USO14C0566.     ********************SYSTEM BASE ID IN OTHER COUNTRIES******************  US114B0005, US114B0006, US114C0081, US114C0082, US114C0107, US114C0110, US114C0143, US114C0144, US114C0145, US114C0146, US114C0147, US114C0148, US114C0192, US114C0193, US114C0194, US114C0211, US114C0238, US114C0309, US114C0320, US114C0348, US114C0363, US114C0366, US114C0408, US114C0409, US114C0442, US114C0446, US114C0532, US115C0017, US115C0052, US115C0053, US115C0054, US115C0100, US115C0101, US115C0137, US115C0138, US115C0141, US115C0178, US115C0179, US115C0180, US115C0181, US115C0212, US115C0213, 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USN14C0031, USN14C0037, USN14C0100, USN14C0143, USN14C0144, USN14C0187, USN14C0188, USN14C0238, USN14C0239, USN14C0310, USN14C0312, USN14C0363, USN14C0364, USN14C0368, USN14C0379, USN14C0381, USN14C0425, USN14C0426, USN14C0465, USN14C0466, USN14C0596, USN14C0597, USN14C0598, USN14C0599, USN14C0600, USN14C0616, USN14C0617, USN14C0623, USN14C0656, USN14C0657, USN14C0693, USN14C0694, USN14C0695, USN14C0730, USN14C0792, USN14C0793, USN14C0794, USN14C0884, USN14C0885, USN14C0888, USN14C0889, USN14C0890, USN14C0891, USN14C0939, USN14C0942, USN14C0946, USN14C1043, USN14C1045, USO13C0359, USO13C0360, USO13C0362, USO13C0363, USO13C0364, USO13C0365, USO13C0366, USO13C0367, USO13C0368, USO13C0369, USO13C0387, USO13C0395, USO13C0398, USO13C0404, USO13C0405, USO13C0406, USO13C0407, USO13C0455, USO13C0456, USO13C0464, USO13C0466, USO13C0467, USO13C0468, USO13C0469, USO13C0482, USO13C0483, USO13C0594, USO13C0596, USO13C0611, USO13C0612, USO13C0614, USO13C0615, USO13C0630, USO13C0679, USO13C0684, USO13C0686, USO14C0029, USO14C0030, USO14C0031, USO14C0032, USO14C0033, USO14C0035, USO14C0036, USO14C0037, USO14C0038, USO14C0039, USO14C0040, USO14C0093, USO14C0094, USO14C0123, USO14C0124, USO14C0277, USO14C0339, USO14C0376, USO14C0438, USO14C0439, USO14C0476, USO14C0477, USO14C0479, USO14C0514, USO14C0515, USO14C0516, USO14C0565, USO14C0567, USO14C0568, USO14C0569, USO14C0607, USO14C0608, USO14C0611, USO14C0612, USO14C0659, USO14C0667, USO14C0718, USO14C0719, USO14C0720, USO14C0763, USO14C0803, USO14C0804, USO14C0844, USO14C0923, USO14C0924, USO14C1115, USO14C1116, USO14C1181, and USO14C1182.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. || Part Number: 989605408541 With || 453561736761 (1.1) || 453561750041 (1.1.1) || 453561753651 (1.1.2) || 453561772231 (1.2) || 453561772611 (1.2.1) || 453561786571 (1.2.2) || 453561785081 (1.3) || 453561800581 (1.3.1) || 453561805181 (1.3.2) || Diagnostic ultrasound imaging and fluid flow analysis.
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • Dirección del fabricante
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA