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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3232-2026

Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);

Publicado el 30 de septiembre de 2026 · Inicio del retiro: 21 de agosto de 2026

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

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

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, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;
Lote
1. Model Numbers (REF): 781196 (Achieva 1.5T); UDI-DI: N/A; Serial Numbers: 22135, 21807, 22149, 22162, 22186, 22264, 21329, 21787, 21989, 22022, 22150, 22180, 22270, 21674, 22080, 21190, 21254, 21315, 21530, 21592, 21903, 21913, 21914, 22072, 22076, 22161, 22176, 22217, 22278, 21796, 21996, 21306, 21499, 21525, 21556, 21626, 21897, 21985, 22213, 22056, 21342, 21571, 21594, 21810, 21924, 22335, 21235, 21492, 22198, 21243, 21449, 22029, 22069, 21731, 22095, 22185, 22239, 22108, 22079, 21984, 21073, 21211, 21269, 21487, 21488, 21550, 21598, 21624, 21808, 22071, 22223, 21911, 21225, 21954, 21215, 21397, 21431, 21689, 21986, 22021, 22243, 21427, 22117, 22326, 21076, 21104, 21183, 21264, 21272, 21284, 21321, 21334, 21351, 21405, 21455, 21479, 21494, 21508, 21572, 21574, 21589, 21666, 21776, 21805, 21868, 21879, 21935, 21957, 21968, 21993, 22001, 22004, 22066, 22130, 22136, 22155, 22207, 22258; 2. Model Numbers (REF): 781343 (Achieva 1.5T); UDI-DI: 884838055292; Serial Numbers: 72020, 72104, 72137, 72138, 72146, 72157, 72160, 72170, 72171, 72179, 72183, 72185, 72200, 72223, 72233, 72238, 72251, 72269, 72013, 72111, 72113, 72231, 72235, 72270, 72271, 72273, 72286, 72079, 72083, 72109, 72120, 72122, 72123, 72124, 72126, 72139, 72141, 72142, 72147, 72150, 72247, 72007, 72156, 72101, 72116, 72117, 72180, 72197, 72267, 72189, 72008, 72080, 72036, 72052, 72057, 72103, 72134, 72143, 72144, 72145, 72151, 72186, 72199, 72217, 72224, 72227, 72228, 72236, 72253, 72254, 72255, 72256, 72257, 72258, 72259, 72260, 72264, 72278, 72279, 72296, 72297, 72298, 72299, 72304, 72029, 72129, 72153, 72175, 72194, 72207, 72281, 72290, 72301, 72302, 72310, 72311, 72316, 72320, 72321, 72326, 72329, 72075, 72076, 72261, 72022, 72047, 72100, 72154, 72159, 72240, 72285, 72287, 72317, 72324, 72015, 72016, 72023, 72071, 72074, 72205, 72038, 72322, 72053, 72063, 72077, 72118, 72121, 72177, 72188, 72192, 72202, 72203, 72265, 72274, 72288, 72289, 72308, 72313, 72048, 72001, 72058, 72230, 72234, 72102, 72201, 72003, 72040, 72114, 72010, 72049, 72055, 72136, 72148, 72266, 72319, 72222, 72034, 72198, 72220, 72226, 72119, 72168, 72303, 72309, 72312, 72318, 72025, 72066, 72193, 72325, 72327, 72331, 72174, 72082, 72249; 3. Model Numbers (REF): 781283 (Achieva 1.5T Conversion); UDI-DI: N/A; Serial Numbers: 39056, 8989, 10126, 39098, 39108, 39004, 39010, 39028, 39032, 39086, 39094, 39095, 39058, 39091, 39105, 39053, 39073, 39067, 39016, 39025; 4. Model Numbers (REF): 781346 (Achieva 1.5 Conversion); UDI-DI: N/A; Serial Numbers: 18052, 8361, 8415, 10015, 75008, 5243, 8727, 10172, 10189, 10545, 18737, 75002, 75003, 75004, 75015, 8059, 8757, 8767, 8842, 8883, 8886, 8897, 8946, 8974, 8981, 8990, 10060, 18001, 18710, 75009, 75092, 75095, 75099, 75100, 8069, 8312, 8520, 10006, 10048, 18588, 75000, 75001, 75005, 75031, 75049, 75087, 8371, 8289, 8367, 8740, 10539, 75011, 8351, 8782, 8756, 75010, 75007, 8124, 8020; 5. Model Numbers (REF): 781178 (Achieva 1.5T Initial System); UDI-DI: N/A; Serial Numbers: 20095, 20056, 20230, 20258, 20085, 20094, 20113, 20050, 20072, 20088, 20096, 20252, 20281, 20297, 20307;
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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Preguntas sobre este retiro

¿Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System); fue retirado del mercado?

Sí. FDA publicó el retiro Z-3232-2026 el 30 de septiembre de 2026. Peligro reportado: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

¿Qué debo hacer si tengo este producto?

Voluntary: Firm initiated · Letter

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