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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2928-2026

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

Publicado el 19 de agosto de 2026 · Inicio del retiro: 29 de junio 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

Firmware issue potentially leading to loss of geometry movements.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Distribuidor
Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Vietnam, Yemen.
Lote
Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838059115(21)100, (01)00884838059115(21)239, (01)00884838054202(21)520, (01)00884838054202(21)1956, (01)00884838054189(21)683, (01)00884838054196(21)351, (01)00884838054202(21)129, (01)00884838059115(21)305, (01)00884838054196(21)332, (01)00884838054202(21)1233, (01)00884838054202(21)2206, (01)00884838054202(21)1690, (01)00884838054202(21)928, (01)00884838054189(21)155, (01)00884838054202(21)317, (01)00884838054202(21)1774, (01)00884838054202(21)2502, (01)00884838054202(21)869, (01)00884838054202(21)668, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054202(21)406, (01)00884838054202(21)540, (01)00884838054202(21)548, (01)00884838054202(21)1017, (01)00884838054202(21)590, (01)00884838054189(21)654, (01)00884838054189(21)786, (01)00884838054196(21)216, (01)00884838054196(21)230, (01)00884838054202(21)596, (01)00884838054202(21)1957, (01)00884838054202(21)110, (01)00884838054202(21)2261, (01)00884838054189(21)1132, (01)00884838054226(21)115, (01)00884838059115(21)259, (01)00884838054202(21)173, (01)00884838054202(21)866, (01)00884838054202(21)1310, (01)00884838059115(21)203, (01)00884838054202(21)1043, (01)00884838054189(21)458, (01)00884838054202(21)466, (01)00884838054226(21)42, (01)00884838054202(21)1077, (01)00884838059115(21)373, (01)00884838054202(21)877, (01)00884838054202(21)896, (01)00884838054202(21)987, (01)00884838054202(21)995, (01)00884838054202(21)1343, (01)00884838054202(21)1439, (01)00884838059115(21)111, (01)00884838054202(21)895, (01)00884838054202(21)265, (01)00884838054202(21)305, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054196(21)1, (01)00884838054202(21)1154, (01)00884838054196(21)71, (01)00884838054202(21)1000, (01)00884838054202(21)1909, (01)00884838054202(21)121, (01)00884838054189(21)436, (01)00884838054202(21)1716, (01)00884838054202(21)1983, (01)00884838054202(21)784, (01)00884838054202(21)2061, (01)00884838054202(21)729, (01)00884838054189(21)1338, (01)00884838054202(21)1393, (01)00884838054189(21)1068, (01)00884838054189(21)233, (01)00884838054202(21)525, (01)00884838054202(21)1948, (01)00884838054202(21)1656, (01)00884838054189(21)78, (01)00884838054202(21)209, (01)00884838054202(21)825, (01)00884838054202(21)1461, (01)00884838054202(21)408, (01)00884838059115(21)38, (01)00884838054202(21)570, (01)00884838054202(21)218, (01)00884838054202(21)734, (01)00884838054202(21)1050, (01)00884838054202(21)1751, (01)00884838054202(21)454, (01)00884838054202(21)1428, (01)00884838054219(21)57, (01)00884838054189(21)432, (01)00884838054202(21)666, (01)00884838054219(21)7, (01)00884838054189(21)224, (01)00884838054202(21)488, (01)00884838054226(21)108, (01)00884838054202(21)1094, (01)00884838054202(21)169, (01)00884838059115(21)23, (01)00884838054202(21)2173, (01)00884838054202(21)1214, (01)00884838054202(21)52, (01)00884838054202(21)66, (01)00884838054202(21)493, (01)00884838054202(21)994, (01)00884838054202(21)373, (01)00884838059115(21)290, (01)00884838054202(21)1213, (01)00884838054226(21)173, (01)00884838054202(21)339, (01)00884838054202(21)234, (01)00884838054189(21)93, (01)00884838054189(21)796, (01)00884838054189(21)1072, (01)00884838054202(21)1836, (01)00884838054202(21)364, (01)00884838054202(21)982, (01)00884838054202(21)634, (01)00884838059115(21)124, (01)00884838054202(21)190, (01)00884838054202(21)818, (01)00884838054202(21)1394, (01)00884838054202(21)1396, (01)00884838054202(21)1646, (01)00884838054202(21)386, (01)00884838054226(21)119, (01)00884838054226(21)126, (01)00884838054202(21)1650, (01)00884838054189(21)543, (01)00884838054202(21)2275, (01)00884838054189(21)1248, (01)00884838054202(21)1058, (01)00884838054189(21)561, (01)00884838059115(21)274, (01)00884838054202(21)1353, (01)00884838054202(21)1466, (01)00884838054196(21)319, (01)00884838
Clasificación de riesgo
Class II
Área (FDA)
device
País
Netherlands

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