FDAFDA · Alimentos y medicamentos·N.º oficial Z-2932-2026
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
Publicado el 19 de agosto de 2026 · Inicio del retiro: 16 de julio 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
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distribuidor
- Worldwide distribution.
- Lote
- UDI: (01)00884838116757(21)5, (01)00884838116771(21)686, (01)00884838116771(21)521, (01)00884838116771(21)812, (01)00884838116771(21)163, (01)00884838116801(21)127, (01)00884838116757(21)34, (01)00884838116733(21)61, (01)00884838116764(21)226, (01)00884838116771(21)327, (01)00884838116764(21)277, (01)00884838116771(21)780, (01)00884838116771(21)429, (01)00884838116764(21)276, (01)00884838116788(21)87, (01)00884838116801(21)37, (01)00884838116771(21)362, (01)00884838116771(21)502, (01)00884838116740(21)77, (01)00884838116757(21)106, (01)00884838116771(21)222, (01)00884838116771(21)545, (01)00884838116801(21)159, (01)00884838116801(21)345, (01)00884838116771(21)987, (01)00884838116771(21)457, (01)00884838116801(21)136, (01)00884838116757(21)49, (01)00884838116771(21)803, (01)00884838116771(21)901, (01)00884838116771(21)347, (01)00884838116764(21)335, (01)00884838116801(21)199, (01)00884838116801(21)24, (01)00884838116771(21)902, (01)00884838116771(21)529, (01)00884838116764(21)99, (01)00884838116740(21)37, (01)00884838116801(21)421, (01)00884838116771(21)718, (01)00884838116801(21)212, (01)00884838116764(21)122, (01)00884838116801(21)17, (01)00884838116764(21)344, (01)00884838116771(21)287, (01)00884838116757(21)140, (01)00884838116764(21)169, (01)00884838116771(21)822, (01)00884838116801(21)25, (01)00884838116801(21)180, (01)00884838116771(21)88, (01)00884838116788(21)127, (01)00884838116771(21)363, (01)00884838116801(21)227, (01)00884838116771(21)716, (01)00884838116771(21)185, (01)00884838116771(21)1145, (01)00884838116771(21)426, (01)00884838116801(21)235, (01)00884838116771(21)292, (01)00884838116771(21)252, (01)00884838116801(21)131, (01)00884838116771(21)332, (01)00884838116771(21)993, (01)00884838116771(21)97, (01)00884838116771(21)359, (01)00884838116771(21)1088, (01)00884838116764(21)350, (01)00884838116771(21)893, (01)00884838116801(21)288, (01)00884838116771(21)346, (01)00884838116771(21)695, (01)00884838116771(21)383, (01)00884838116771(21)300, (01)00884838116771(21)804, (01)00884838116801(21)504, (01)00884838116771(21)186, (01)00884838116764(21)267, (01)00884838116771(21)1354, (01)00884838116771(21)1246, (01)00884838116771(21)99, (01)00884838116771(21)413, (01)00884838116801(21)231, (01)00884838116771(21)547, (01)00884838116771(21)449, (01)00884838116757(21)99, (01)00884838116801(21)203, (01)00884838116771(21)75, (01)00884838116771(21)813, (01)00884838116801(21)138, (01)00884838116771(21)447, (01)00884838116771(21)915, (01)00884838116771(21)511, (01)00884838116788(21)117, (01)00884838116801(21)426, (01)00884838116801(21)20, (01)00884838116771(21)484, (01)00884838116801(21)249, (01)00884838116757(21)392, (01)00884838116771(21)626, (01)00884838116771(21)215, (01)00884838116764(21)96, (01)00884838116771(21)704, (01)00884838116764(21)108, (01)00884838116771(21)248, (01)00884838116771(21)594, (01)00884838116771(21)87, (01)00884838116771(21)333, (01)00884838116788(21)76, (01)00884838116771(21)1226, (01)00884838116771(21)927, (01)00884838116771(21)1037, (01)00884838116771(21)1140, (01)00884838116771(21)286, (01)00884838116771(21)173, (01)00884838116771(21)395, (01)00884838116801(21)200, (01)00884838116757(21)12, (01)00884838116771(21)68, (01)00884838116801(21)468, (01)00884838116771(21)656, (01)00884838116801(21)208, (01)00884838116771(21)459, (01)00884838116771(21)848, (01)00884838116757(21)138, (01)00884838116801(21)42, (01)00884838116771(21)71, (01)00884838116771(21)465, (01)00884838116801(21)205, (01)00884838116771(21)855, (01)00884838116801(21)183, (01)00884838116757(21)101, (01)00884838116771(21)377, (01)00884838116771(21)854, (01)00884838116771(21)517, (01)00884838116771(21)330, (01)00884838116801(21)363, (01)00884838116771(21)370, (01)00884838116757(21)91, (01)00884838116771(21)660, (01)00884838116771(21)501, (01)00884838116771(21)535, (01)00884838116771(21)463, (01)00884838116771(21)320, (01)00884838116771(21)1248, (01)00884838116801(21)81, (01)00884838116771(21)817, (01)00884838116771(21)516, (01)00884838116771
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Netherlands
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