Volver al buscador
FDAFDA · Alimentos y medicamentos·N.º oficial Z-0368-2014

EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.

Publicado el 27 de noviembre de 2013 · Inicio del retiro: 17 de octubre de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Philips Medical Systems North America Inc.
Distribuidor
Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Ireland, Republic of Korea, Latvia, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and United Kingdom.
Lote
TRACE ITEM SERIAL NUMBERS in the UNITED STATES: US713B0171, US713B0207, US813B0017, US813B0018, US813B0019, US813B0020, US813B0022, US813B0023, US813B0024, US813B0025, US813B0122, US813B0123, US813B0125, US813B0127, US813B0128, US813B0129, US813B0131, US813B0132, US813B0134, US813B0135, US813B0233, US813B0234, US813B0235, US813B0236, US813B0237, US813B0238, US813B0239, US813B0240, US813B0423, US813B0424, US813B0425, US813B0426, US813B0427, US813B0428, US813B0429, US813B0430, US813B0431, US813B0432, US813B0433, US813B0434, US913B0033, US913B0034, US913B0035, US913B0036, US913B0037, US913B0038, US913B0039, US913B0040, US913B0057, US913B0060, US913B0061, US913B0062, US913B0063, US913B0064, US913B0065, US913B0066, US913B0106, US913B0107, US913B0108, US913B0109, US913B0110, US913B0111, US913B0112, US913B0113, US913B0144, US913B0176, US913B0201, US913B0256, US913B0257, US913B0350, US913B0363, US913B0364, US913B0365, US913B0366, US913B0367, US913B0368, US913B0369, US913B0380, US913B0384, US913B0395, US913B0396, US913B0397, US913B0398, US913B0399, US913B0400, US913B0401, US913B0402, US913B0409, US913B0441, US913B0444, US913B0445, US913B0446, US913B0447, US913B0503, US913B0522, US913B0614, US913B0615, US913B0616, US913B0618, US913B0619, and USO13B0043. TRACE ITEM SERIAL NUMBERS INTERNATIONAL: US513B0224, US513B0295, US513B0387, US513B0560, US613B0299, US713B0085, US713B0086, US713B0118, US713B0119, US713B0120, US713B0122, US713B0123, US713B0126, US713B0149, US713B0171, US713B0172, US713B0192, US713B0193, US713B0194, US713B0195, US713B0204, US713B0205, US713B0206, US713B0208, US713B0324, US713B0325, US713B0358, US713B0359, US713B0437, US713B0439, US713B0440, US713B0532, US713B0537, US713B0573, US713B0574, US713B0575, US713B0576, US713B0577, US713B0578, US713B0579, US713B0580, US713B0581, US713B0582, US713B0583, US713B0584, US713B0586, US713B0587, US713B0588, US713B0589, US713B0590, US713B0592, US713B0593, US713B0594, US713B0595, US813B0015, US813B0016, US813B0032, US813B0037, US813B0038, US813B0039, US813B0121, US813B0151, US813B0152, US813B0153, US813B0154, US813B0155, US813B0156, US813B0157, US813B0158, US813B0159, US813B0160, US813B0161, US813B0162, US813B0163, US813B0164, US813B0183, US813B0184, US813B0185, US813B0186, US813B0187, US813B0188, US813B0189, US813B0190, US813B0191, US813B0192, US813B0193, US813B0194, US813B0195, US813B0196, US813B0232, US813B0396, US813B0397, US813B0398, US813B0399, US813B0400, US813B0401, US813B0402, US813B0403, US813B0404, US813B0405, US813B0406, US813B0407, US813B0408, US813B0409, US813B0410, US813B0411, US813B0468, US813B0469, US813B0470, US813B0471, US813B0472, US813B0473, US813B0474, US813B0475, US813B0476, US813B0477, US813B0478, US813B0479, US813B0480, US913B0026, US913B0027, US913B0028, US913B0029, US913B0030, US913B0031, US913B0032, US913B0041, US913B0051, US913B0059, US913B0085, US913B0086, US913B0101, US913B0102, US913B0103, US913B0104, US913B0105, US913B0130, US913B0132, US913B0133, US913B0134, US913B0135, US913B0137, US913B0138, US913B0139, US913B0140, US913B0141, US913B0142, US913B0143, US913B0177, US913B0178, US913B0179, US913B0185, US913B0202, US913B0216, US913B0217, US913B0218, US913B0219, US913B0220, US913B0221, US913B0222, US913B0223, US913B0232, US913B0252, US913B0253, US913B0254, US913B0255, US913B0259, US913B0260, US913B0299, US913B0300, US913B0301, US913B0302, US913B0303, US913B0316, US913B0317, US913B0318, US913B0319, US913B0332, US913B0333, US913B0336, US913B0337, US913B0338, US913B0339, US913B0340, US913B0349, US913B0359, US913B0360, US913B0385, US913B0408, US913B0458, US913B0459, US913B0486, US913B0487, US913B0488, US913B0489, US913B0490, US913B0499, US913B0504, US913B0505, US913B0506, US913B0565, US913B0566, US913B0567, US913B0568, USO13B0040, and USO13B0041.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta