FDAFDA · Alimentos y medicamentos·N.º oficial Z-2170-2026
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
Publicado el 20 de mayo de 2026 · Inicio del retiro: 31 de marzo 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 for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distribuidor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lote
- 1. System Code Description: Azurion 3 M12. Model Number [UDI]: 722221 [(01)00884838099203(21)181, (01)00884838099203(21)178, (01)00884838099203(21)93]; 722229 [(01)00884838116726(21)22, (01)00884838116726(21)9, (01)00884838116726(21)16, (01)00884838116726(21)15, (01)00884838116726(21)5, (01)00884838116726(21)3, (01)00884838116726(21)4, (01)00884838116726(21)6, (01)00884838116726(21)2, (01)00884838116726(21)8]. 2. System Code Description: Azurion 3 M15. Model Number [UDI]: 722222 [(01)00884838099210(21)358, (01)00884838099210(21)328, (01)00884838099210(21)389, (01)00884838099210(21)378, (01)00884838099210(21)243, (01)00884838099210(21)392, (01)00884838099210(21)396, (01)00884838099210(21)13, (01)00884838099210(21)379, (01)00884838099210(21)385, (01)00884838099210(21)376, (01)00884838099210(21)366, (01)00884838099210(21)365, (01)00884838099210(21)398, (01)00884838099210(21)274]; 722230 [(01)00884838116733(21)40, (01)00884838116733(21)2, (01)00884838116733(21)41, (01)00884838116733(21)15, (01)00884838116733(21)28, (01)00884838116733(21)38, (01)00884838116733(21)9, (01)00884838116733(21)27, (01)00884838116733(21)13]. 3. System Code Description: Azurion 5. Model Number [UDI]: 722281 [(01)00884838110564(21)401, (01)00884838110564(21)427, (01)00884838110564(21)382, (01)00884838110564(21)425]. 4. System Code Description: Azurion 5 M12. Model Number [UDI]: 722227 [(01)00884838099227(21)265, (01)00884838099227(21)360, (01)00884838099227(21)320, (01)00884838099227(21)338, (01)00884838099227(21)324, (01)00884838099227(21)305, (01)00884838099227(21)356, (01)00884838099227(21)346, (01)00884838099227(21)313, (01)00884838099227(21)339, (01)00884838099227(21)321, (01)00884838099227(21)247, (01)00884838099227(21)298, (01)00884838099227(21)337, (01)00884838099227(21)306, (01)00884838099227(21)336, (01)00884838099227(21)318, (01)00884838099227(21)353, (01)00884838099227(21)309, (01)00884838099227(21)310, (01)00884838099227(21)316, (01)00884838099227(21)272, (01)00884838099227(21)345, (01)00884838099227(21)351, (01)00884838099227(21)352, (01)00884838099227(21)258, (01)00884838099227(21)326, (01)00884838099227(21)348, (01)00884838099227(21)355, (01)00884838099227(21)315, (01)00884838099227(21)280, (01)00884838099227(21)300, (01)00884838099227(21)335, (01)00884838099227(21)344, (01)00884838099227(21)308, (01)00884838099227(21)362, (01)00884838099227(21)323, (01)00884838099227(21)331, (01)00884838099227(21)269, (01)00884838099227(21)294, (01)00884838099227(21)342, (01)00884838099227(21)330, (01)00884838099227(21)340, (01)00884838099227(21)284, (01)00884838099227(21)333, (01)00884838099227(21)253, (01)00884838099227(21)301, (01)00884838099227(21)332, (01)00884838099227(21)334, (01)00884838099227(21)297, (01)00884838099227(21)350, (01)00884838099227(21)307, (01)00884838099227(21)311, (01)00884838099227(21)319, (01)00884838099227(21)286, (01)00884838099227(21)329, (01)00884838099227(21)208, (01)00884838099227(21)178]; 722231 [(01)00884838116740(21)52, (01)00884838116740(21)49, (01)00884838116740(21)50, (01)00884838116740(21)41, (01)00884838116740(21)21, (01)00884838116740(21)53, (01)00884838116740(21)47, (01)00884838116740(21)3, (01)00884838116740(21)25, (01)00884838116740(21)34, (01)00884838116740(21)61, (01)00884838116740(21)26, (01)00884838116740(21)7, (01)00884838116740(21)8, (01)00884838116740(21)4, (01)00884838116740(21)5, (01)00884838116740(21)12, (01)00884838116740(21)60, (01)00884838116740(21)28, (01)00884838116740(21)45, (01)00884838116740(21)20, (01)00884838116740(21)19, (01)00884838116740(21)51, (01)00884838116740(21)29, (01)00884838116740(21)27, (01)00884838116740(21)11, (01)00884838116740(21)35, (01)00884838116740(21)62, (01)00884838116740(21)54, (01)00884838116740(21)33, (01)00884838116740(21)1, (01)00884838116740(21)2, (01)00884838116740(21)32]. 5. System Code Description: Azurion 5 M20. Model Number [UDI]: 722228 [(01)00884838099234(21)481, (01)00884838099234(21)537, (01)00884838099234(21)615, (01)00884838099234(21)538, (01)00
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Netherlands
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