FDAFDA · Alimentos y medicamentos·N.º oficial Z-2289-2026

Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Publicado el 10 de junio de 2026 · Inicio del retiro: 7 de diciembre de 2023

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

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Qué hacer

Letter

Detalles del retiro

Fabricante: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Distribuidor: US Nationwide distribution.
Lote: UDI (01)00884838085367(21)547, (01)00884838099272(21)120, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099272(21)124, (01)00884838099272(21)125, (01)00884838099272(21)126, (01)00884838099272(21)127, (01)00884838099272(21)153, (01)00884838099272(21)67, (01)00884838099272(21)209, (01)00884838099272(21)271, (01)00884838099272(21)675, (01)00884838099272(21)112, (01)00884838085367(21)467, (01)00884838085367(21)335, (01)00884838099272(21)113, (01)00884838099272(21)121, (01)00884838099272(21)139, (01)00884838099272(21)158, (01)00884838085367(21)455, (01)00884838085367(21)494, (01)00884838099272(21)239, (01)00884838099272(21)105, (01)00884838099272(21)678, (01)00884838099272(21)362, (01)00884838099272(21)114, (01)00884838085367(21)564, (01)00884838099272(21)403, (01)00884838085367(21)418, (01)00884838085367(21)440, (01)00884838099272(21)108, (01)00884838099272(21)545, (01)00884838099272(21)197, (01)00884838099272(21)380, (01)00884838099272(21)281, (01)00884838099272(21)495, (01)00884838099272(21)319, (01)00884838099272(21)339, (01)00884838099272(21)182, (01)00884838099272(21)183, (01)00884838085367(21)64, (01)00884838099272(21)325, (01)00884838099272(21)100, (01)00884838099272(21)272, (01)00884838099272(21)680, (01)00884838085367(21)42, (01)00884838099272(21)255, (01)00884838099272(21)341, (01)00884838099272(21)687, (01)00884838099272(21)350, (01)00884838099272(21)280, (01)00884838085367(21)323, (01)00884838099272(21)270, (01)00884838099272(21)254, (01)00884838099272(21)107, (01)00884838099272(21)144, (01)00884838085367(21)109, (01)00884838099272(21)294, (01)00884838099272(21)559, (01)00884838099272(21)98, (01)00884838099272(21)343, (01)00884838085367(21)443, (01)00884838099272(21)301, (01)00884838099272(21)117, (01)00884838085367(21)322, (01)00884838085367(21)373, (01)00884838085367(21)442, (01)00884838099272(21)244, (01)00884838099272(21)332, (01)00884838085367(21)308, (01)00884838099272(21)78, (01)00884838099272(21)374, (01)00884838099272(21)11, (01)00884838085367(21)354, (01)00884838099272(21)441, (01)00884838099272(21)129, (01)00884838099272(21)180, (01)00884838085367(21)279, (01)00884838099272(21)442, (01)00884838085367(21)400, (01)00884838099272(21)220, (01)00884838099272(21)189, (01)00884838099272(21)190, (01)00884838099272(21)446, (01)00884838085367(21)510, (01)00884838085367(21)111, (01)00884838085367(21)113, (01)00884838085367(21)446, (01)00884838099272(21)208, (01)00884838099272(21)554, (01)00884838085367(21)330, (01)00884838085367(21)288, (01)00884838099272(21)360, (01)00884838099272(21)337, (01)00884838099272(21)159, (01)00884838099272(21)326, (01)00884838099272(21)400, (01)00884838085367(21)329, (01)00884838099272(21)175, (01)00884838099272(21)427, (01)00884838099272(21)464, (01)00884838099272(21)468, (01)00884838085367(21)472, (01)00884838085367(21)470, (01)00884838085367(21)457, (01)00884838085367(21)520, (01)00884838085367(21)490, (01)00884838099272(21)143, (01)00884838099272(21)262, (01)00884838085367(21)103, (01)00884838099272(21)391, (01)00884838085367(21)150, (01)00884838085367(21)277, (01)00884838099272(21)173, (01)00884838085367(21)172, (01)00884838099272(21)147, (01)00884838099272(21)204, (01)00884838099272(21)467, (01)00884838085367(21)356, (01)00884838085367(21)130, (01)00884838099272(21)260, (01)00884838099272(21)381, (01)00884838099272(21)508, (01)00884838099272(21)419, (01)00884838099272(21)313, (01)00884838085367(21)469, (01)00884838099272(21)472, (01)00884838099272(21)318, (01)00884838099272(21)473, (01)00884838085367(21)431, (01)00884838099272(21)174, (01)00884838099272(21)383, (01)00884838099272(21)181, (01)00884838099272(21)463, (01)00884838099272(21)205, (01)00884838099272(21)59, (01)00884838099272(21)361, (01)00884838085367(21)114, (01)00884838099272(21)555, (01)00884838099272(21)379, (01)00884838085367(21)511, (01)00884838085367(21)477, (01)00884838099272(21)266, (01)00884838099272(21)398, (01)00884838099272(21)593, (01)00884838099272(21)75, (01)00884838099272(21)19, (01)00884
Clasificación de riesgo: Class II
Área (FDA): device
País: Netherlands

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