FDAFDA · Alimentos y medicamentos·N.º oficial Z-2225-2026
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.
Publicado el 27 de mayo de 2026 · Inicio del retiro: 28 de abril 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
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distribuidor
- Nationwide distribution. International distribution to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, C¿te D'Ivoire, El Salvador, Estonia, Greece, Honduras, Hong Kong, Iceland, Indonesia, Iraq, Japan, Kyrgyzstan, Malaysia, Malta, Moldova, Nepal, New Zealand, Philippines, Qatar, Singapore, South Africa, Sri Lanka, Syrian Arab Republic, Tanzania, Turkmenistan, Vietnam, Yemen
- Lote
- 1. Model Number [UDI]: 722063 [(01)00884838085275(21)77, (01)00884838085275(21)47, (01)00884838085275(21)146, (01)00884838085275(21)102, (01)00884838085275(21)43, (01)00884838085275(21)2, (01)00884838085275(21)99, (01)00884838085275(21)28, (01)00884838085275(21)144, (01)00884838085275(21)62, (01)00884838085275(21)119, (01)00884838085275(21)61, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)120, (01)00884838085275(21)121, (01)00884838085275(21)110, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)97, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)116, (01)00884838085275(21)93, (01)00884838085275(21)141, (01)00884838085275(21)115, (01)00884838085275(21)137, (01)00884838085275(21)150, (01)00884838085275(21)128, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)129, (01)00884838085275(21)78, (01)00884838085275(21)76, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)92, (01)00884838085275(21)139, (01)00884838085275(21)130, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)24, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)27, (01)00884838085275(21)15, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)87, (01)00884838085275(21)85, (01)00884838085275(21)89, (01)00884838085275(21)88, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55]; 722229 [(01)00884838116726(21)7, (01)00884838116726(21)3, (01)00884838116726(21)10, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13]. 2. Model Number [UDI]: 722064 [(01)00884838085282(21)513, (01)00884838085282(21)61, (01)00884838085282(21)162, (01)00884838085282(21)161, (01)00884838085282(21)297, (01)00884838085282(21)169, (01)00884838085282(21)131, (01)00884838085282(21)479, (01)00884838085282(21)190, (01)00884838085282(21)359, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)256, (01)00884838085282(21)290, (01)00884838085282(21)502, (01)00884838085282(21)425, (01)00884838085282(21)89, (01)00884838085282(21)303, (01)00884838085282(21)130, (01)00884838085282(21)157, (01)00884838085282(21)60, (01)00884838085282(21)253, (01)00884838085282(21)280, (01)00884838085282(21)373, (01)00884838085282(21)417, (01)00884838085282(21)277, (01)00884838085282(21)102, (01)00884838085282(21)467, (01)00884838085282(21)461, (01)00884838085282(21)137, (01)00884838085282(21)84, (01)00884838085282(21)510, (01)00884838085282(21)49, (01)00884838085282(21)246, (01)00884838085282(21)282, (01)00884838085282(21)354, (01)00884838085282(21)374, (01)00884838085282(21)274, (01)00884838085282(21)127, (01)00884838085282(21)106, (01)00884838085282(21)329, (01)00884838085282(21)276, (01)00884838085282(21)58, (01)00884838085282(21)81, (01)00884838085282(21)200, (01)00884838085282(21)179, (01)00884838085282(21)249, (01)00884838085282(21)156, (01)00884838085282(21)380, (01)00884838085282(21)288, (01)00884838085282(21)231, (01)00884838085282(21)287, (01)00884838085282(21)150, (01)00884838085282(21)233, (01)00884838085282(21)230, (01)00884838085282(21)44, (01)00884838085282(21)176, (01)00884838085282(21)149, (01)00884838085282(21)197, (01)00884838085282(21)289, (01)00884838085282(21)184, (01)00884838085282(21)6, (01)00884838085282(21)448, (01)00884838085282(21)10, (01)00884838085282(21)82, (01)00884838085282(21)35, (01)00884838085282(21)278, (01)00884838085282(21)55, (01)00884838085282(21)39, (01)00884838085282(21)45, (01)00884838085282(21)66, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)484,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Netherlands
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