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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1589-2024

SmartPath to dStream for 1.5T, Magnetic Resonance System.

Publicado el 24 de abril de 2024 · Inicio del retiro: 12 de marzo de 2024

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

Qué peligro representa

Patient support table floor plate may be incorrectly installed.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Philips North America Llc
Distribuidor
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.
Lote
Model No. 781260, 782112; UDI-DI 884838095076, 884838098886; Serial No. 8954, 18726, 32174, 21664, 8906, 8578, 10703, 8835, 10154, 8971, 20226, 9001, 21665, 20204, 21108, 5475, 12033, 39024, 10196, 32131, 8630, 12034, 8772, 8091, 21555, 21294, 18561, 18761, 10482, 18800, 22285, 8560, 21788, 11064, 30146, 8100, 10036, 13052, 21023, 21290, 32094, 21223, 10717, 32142, 12134, 5572, 8378, 21003, 39103, 8566, 8190, 5523, 10511, 21611, 21612, 21888, 32184, 12084, 39003, 10079, 20198, 13032, 20071, 8642, 8318, 72054, 10170, 8178, 10174, 9022, 8087, 8923, 21438, 8591, 21033, 13018, 11030, 8119, 18665, 8427, 10061, 8895, 8706, 21253, 5511, 8601, 18808, 18655, 22060, 8608, 8352, 8481, 5490, 5479, 8819, 39005, 8118, 11031, 8857, 10915, 11042, 10544, 8948, 21019, 32450, 18663, 8646, 8884, 22098, 32506, 22127, 13062, 21175, 10075, 18801, 10164, 10498, 21880, 18690, 22299, 20111, 21050, 5466, 8084, 13047, 10029, 21142, 8611, 8395, 8311, 8786, 8215, 9013, 8554, 12115, 8783, 8260, 8478, 13011, 8639, 9004, 10139, 5546, 8387, 8896, 22154, 21278, 10191, 21129, 32221, 32218, 32449, 32443, 32445, 32444, 11085, 18644, 21067, 72243, 9007, 8712, 8942, 10183, 8667, 12030, 5463, 21912, 12114, 18038, 5537, 13029, 8025, 18101, 10457, 8750, 8752, 10044, 11091, 21498, 12072, 11062, 32311, 21554, 8057, 8779, 8746, 12055, 13069, 8559, 18565, 8309, 21156, 32147, 32410, 11046, 10554, 18511, 10220, 20057, 21481, 21679, 11102, 18631, 8200, 32849, 32513, 9006, 18610, 10906, 10130, 8086, 21560, 32264, 8804, 8021, 5447, 21697, 10513, 20033, 20302, 8831, 18970, 21676, 8840, 32180, 21084, 11076, 32374, 32742, 8330, 21015, 32621, 18512, 20112, 8392, 21458, 21184, 32361, 32140, 33126, 32492, 13046, 21759, 8365, 10900, 39037, 8641, 8060, 13001, 10185, 32405, 32643, 21466, 32200, 30037, 10719, 10086, 22107, 11000, 32176, 8407, 22342, 32752, 8240, 10913, 10570, 21062, 21942, 33100, 11001, 18509, 18035, 18697, 8531, 8512, 8985, 10523, 20319, 10151, 18060, 8010, 18558, 20151, 20152, 32710, 5505, 18597, 8354, 10033, 10716, 18673, 18701, 22189, 8704, 32636, 8129, 18069, 5539, 12036, 11072, 32438, 21691, 21171, 39031, 8251, 32092, 8263, 8397, 21680, 8156, 18929, 21392, 10179, 20002, 33051, 12047, 21623, 21969, 32391, 20322, 22102, 11108, 8843, 21929, 20116, 13082, 32127, 32113, 20237, 32341, 5499, 22055, 32990, 30067, 20011, 18107, 8760, 20278, 8983, 32754, 8305, 20003, 21349, 20195, 22296, 21355, 8723, 21384, 21591, 22103, 32822, 21748, 32334, 20211, 32245, 8913, 8713, 21222, 21011, 8168, 18746, 8292, 18704, 8110, 11005, 20164, 22013, 21987, 21551, 11017, 22301, 8094, 21583, 8561, 20209, 8451, 10543, 21780, 22100, 22137, 32296, 18938, 21694, 18957, 32049, 20187, 22220, 8711, 21640, 21182, 21403, 21213, 21804, 18720, 8887, 21209, 12120, 21579, 22070, 10552, 21519, 10007, 18524, 32454, 21736, 9020, 8550, 21448, 11018, 22227, 21141, 21477, 72081, 18699, 12082, 20196, 18954, 21249, 11100, 30097, 8736, 20115, 8885, 33220, 9024, 21018, 21892, 22194, 8074, 21362, 21768, 21814, 32680, 32807, 21621, 32283, 8492, 8862, 21775, 32099, 32163, 10117, 5484, 22184, 18853, 8315, 18017, 8657, 8476, 8401, 32573, 18906, 22144, 21453, 33352, 33023, 8694, 18985, 32145, 18986, 10530, 20413, 8045, 18583, 33062, 22237, 18013, 22248, 8975, 32467, 32059, 72239, 32217, 18948, 22157, 8517, 21082, 32258, 8486, 5536, 21710, 39009, 21247, 22044, 18575, 22347, 22175, 8321, 21133, 32164, 18718, 20035, 10008, 21089, 22123, 8175, 10528, 18894, 21890, 21577, 21326, 5425, 39018, 32340, 32119, 32322, 10102, 13023, 21127, 21809, 32236, 32845, 32478, 8096, 30132, 21979, 8213, 32132, 33385, 32778, 32285, 22031, 18559, 32286, 10161, 8456, 32839, 12121, 22266, 32923, 20165, 32134, 32262, 10461, 13026, 21359, 18965, 18851, 32953, 8166, 21792, 33106, 22255, 22257, 22256, 21333, 20182, 33215, 33366, 32359, 12009, 21138, 33044, 22152, 9032, 18548, 5550, 32670, 18574, 8424, 30239, 18788, 18988, 32333, 21746, 32316, 18670, 21671, 20160, 30033, 30139, 21994, 32458, 72250, 21995, 33246, 18803, 33716, 12053, 8798, 10169, 8109, 2
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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