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RecallWatchMedical Device Safety
Class IIOngoingZ-2227-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported May 27, 2026 · 1 month ago
Legal News Analyst ·

Reason for recall

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).

Lot / code information

Model
722063
UDI
(01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)77, (01)00884838085275(21)82, (01)00884838085275(21)47, (01)00884838085275(21)80 — +65 moreShow all
(01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)77, (01)00884838085275(21)82, (01)00884838085275(21)47, (01)00884838085275(21)80, (01)00884838085275(21)102, (01)00884838085275(21)117, (01)00884838085275(21)2, (01)00884838085275(21)99, (01)00884838085275(21)44, (01)00884838085275(21)3, (01)00884838085275(21)62, (01)00884838085275(21)61, (01)00884838085275(21)22, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)25, (01)00884838085275(21)19, (01)00884838085275(21)18, (01)00884838085275(21)17, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)101, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)93, (01)00884838085275(21)115, (01)00884838085275(21)73, (01)00884838085275(21)128, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)72, (01)00884838085275(21)38, (01)00884838085275(21)21, (01)00884838085275(21)78, (01)00884838085275(21)23, (01)00884838085275(21)76, (01)00884838085275(21)63, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)51, (01)00884838085275(21)92, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)54, (01)00884838085275(21)46, (01)00884838085275(21)26, (01)00884838085275(21)71, (01)00884838085275(21)106, (01)00884838085275(21)83, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)27, (01)00884838085275(21)15, (01)00884838085275(21)85, (01)00884838085275(21)88, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)79, (01)00884838085275(21)81, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)55, 2. Azurion 3 M15
Model
722064
UDI
(01)00884838085282(21)209, (01)00884838085282(21)201, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)61, (01)00884838085282(21)161 — +139 moreShow all
(01)00884838085282(21)209, (01)00884838085282(21)201, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)61, (01)00884838085282(21)161, (01)00884838085282(21)162, (01)00884838085282(21)169, (01)00884838085282(21)131, (01)00884838085282(21)190, (01)00884838085282(21)220, (01)00884838085282(21)173, (01)00884838085282(21)89, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)9, (01)00884838085282(21)102, (01)00884838085282(21)137, (01)00884838085282(21)84, (01)00884838085282(21)78, (01)00884838085282(21)49, (01)00884838085282(21)213, (01)00884838085282(21)212, (01)00884838085282(21)193, (01)00884838085282(21)214, (01)00884838085282(21)180, (01)00884838085282(21)185, (01)00884838085282(21)186, (01)00884838085282(21)127, (01)00884838085282(21)106, (01)00884838085282(21)58, (01)00884838085282(21)81, (01)00884838085282(21)200, (01)00884838085282(21)179, (01)00884838085282(21)156, (01)00884838085282(21)230, (01)00884838085282(21)176, (01)00884838085282(21)150, (01)00884838085282(21)149, (01)00884838085282(21)44, (01)00884838085282(21)184, (01)00884838085282(21)6, (01)00884838085282(21)10, (01)00884838085282(21)82, (01)00884838085282(21)35, (01)00884838085282(21)69, (01)00884838085282(21)39, (01)00884838085282(21)66, (01)00884838085282(21)45, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)55, (01)00884838085282(21)36, (01)00884838085282(21)94, (01)00884838085282(21)104, (01)00884838085282(21)155, (01)00884838085282(21)132, (01)00884838085282(21)67, (01)00884838085282(21)183, (01)00884838085282(21)70, (01)00884838085282(21)50, (01)00884838085282(21)138, (01)00884838085282(21)151, (01)00884838085282(21)5, (01)00884838085282(21)208, (01)00884838085282(21)57, (01)00884838085282(21)222, (01)00884838085282(21)98, (01)00884838085282(21)79, (01)00884838085282(21)65, (01)00884838085282(21)87, (01)00884838085282(21)109, (01)00884838085282(21)75, (01)00884838085282(21)46, (01)00884838085282(21)101, (01)00884838085282(21)121, (01)00884838085282(21)68, (01)00884838085282(21)91, (01)00884838085282(21)74, (01)00884838085282(21)73, (01)00884838085282(21)124, (01)00884838085282(21)191, (01)00884838085282(21)122, (01)00884838085282(21)119, (01)00884838085282(21)11, (01)00884838085282(21)48, (01)00884838085282(21)147, (01)00884838085282(21)133, (01)00884838085282(21)7, (01)00884838085282(21)235, (01)00884838085282(21)120, (01)00884838085282(21)100, (01)00884838085282(21)51, (01)00884838085282(21)118, (01)00884838085282(21)62, (01)00884838085282(21)123, (01)00884838085282(21)177, (01)00884838085282(21)47, (01)00884838085282(21)272, (01)00884838085282(21)110, (01)00884838085282(21)59, (01)00884838085282(21)167, (01)00884838085282(21)174, (01)00884838085282(21)165, (01)00884838085282(21)41, (01)00884838085282(21)148, (01)00884838085282(21)182, (01)00884838085282(21)112, (01)00884838085282(21)86, (01)00884838085282(21)198, (01)00884838085282(21)206, (01)00884838085282(21)136, (01)00884838085282(21)143, (01)00884838085282(21)226, (01)00884838085282(21)43, (01)00884838085282(21)80, (01)00884838085282(21)12, (01)00884838085282(21)285, (01)00884838085282(21)215, (01)00884838085282(21)164, (01)00884838085282(21)114, (01)00884838085282(21)144, (01)00884838085282(21)227, (01)00884838085282(21)126, (01)00884838085282(21)92, (01)00884838085282(21)284, (01)00884838085282(21)175, (01)00884838085282(21)199, (01)00884838085282(21)188, (01)00884838085282(21)172, (01)00884838085282(21)210, (01)00884838085282(21)134, (01)00884838085282(21)207, (01)00884838085282(21)192, (01)00884838085282(21)116, (01)00884838085282(21)221, (01)00884838085282(21)189, (01)00884838085282(21)117, (01)00884838085282(21)187, (01)00884838085282(21)166, (01)00884838085282(21)96, (01)00884838085282(21)135, (01)00884838085282(21)108, (01)00884838085282(21)37, 3. Azurion 7 B12
Model
722067
UDI
(01)00884838085350(21)42, (01)00884838085350(21)173, (01)00884838085350(21)109, (01)00884838085350(21)192, (01)00884838085350(21)92, (01)00884838085350(21)103 — +132 moreShow all
(01)00884838085350(21)42, (01)00884838085350(21)173, (01)00884838085350(21)109, (01)00884838085350(21)192, (01)00884838085350(21)92, (01)00884838085350(21)103, (01)00884838085350(21)114, (01)00884838085350(21)69, (01)00884838085350(21)41, (01)00884838085350(21)98, (01)00884838085350(21)81, (01)00884838085350(21)123, (01)00884838085350(21)46, (01)00884838085350(21)115, (01)00884838085350(21)150, (01)00884838085350(21)163, (01)00884838085350(21)131, (01)00884838085350(21)71, (01)00884838085350(21)75, (01)00884838085350(21)132, (01)00884838085350(21)147, (01)00884838085350(21)104, (01)00884838085350(21)36, (01)00884838085350(21)70, (01)00884838085350(21)141, (01)00884838085350(21)26, (01)00884838085350(21)148, (01)00884838085350(21)133, (01)00884838085350(21)57, (01)00884838085350(21)190, (01)00884838085350(21)128, (01)00884838085350(21)151, (01)00884838085350(21)68, (01)00884838085350(21)111, (01)00884838085350(21)43, (01)00884838085350(21)33, (01)00884838085350(21)146, (01)00884838085350(21)187, (01)00884838085350(21)74, (01)00884838085350(21)154, (01)00884838085350(21)157, (01)00884838085350(21)29, (01)00884838085350(21)59, (01)00884838085350(21)209, (01)00884838085350(21)95, (01)00884838085350(21)169, (01)00884838085350(21)127, (01)00884838085350(21)30, (01)00884838085350(21)23, (01)00884838085350(21)203, (01)00884838085350(21)138, (01)00884838085350(21)34, (01)00884838085350(21)53, (01)00884838085350(21)113, (01)00884838085350(21)140, (01)00884838085350(21)144, (01)00884838085350(21)60, (01)00884838085350(21)45, (01)00884838085350(21)107, (01)00884838085350(21)112, (01)00884838085350(21)134, (01)00884838085350(21)101, (01)00884838085350(21)100, (01)00884838085350(21)58, (01)00884838085350(21)47, (01)00884838085350(21)176, (01)00884838085350(21)64, (01)00884838085350(21)156, (01)00884838085350(21)52, (01)00884838099265(21)1, (01)00884838085350(21)55, (01)00884838085350(21)54, (01)00884838085350(21)165, (01)00884838085350(21)25, (01)00884838085350(21)35, (01)00884838085350(21)149, (01)00884838085350(21)32, (01)00884838085350(21)224, (01)00884838085350(21)76, (01)00884838085350(21)108, (01)00884838099265(21)17, (01)00884838085350(21)48, (01)00884838085350(21)102, (01)00884838085350(21)105, (01)00884838085350(21)99, (01)00884838085350(21)21, (01)00884838085350(21)159, (01)00884838085350(21)49, (01)00884838085350(21)185, (01)00884838085350(21)51, (01)00884838085350(21)239, (01)00884838085350(21)40, (01)00884838085350(21)94, (01)00884838085350(21)63, (01)00884838085350(21)96, (01)00884838085350(21)129, (01)00884838085350(21)186, (01)00884838085350(21)130, (01)00884838085350(21)161, (01)00884838085350(21)120, (01)00884838085350(21)170, (01)00884838085350(21)171, (01)00884838085350(21)80, (01)00884838085350(21)28, (01)00884838085350(21)145, (01)00884838085350(21)79, (01)00884838085350(21)93, (01)00884838085350(21)137, (01)00884838085350(21)50, (01)00884838085350(21)44, (01)00884838085350(21)38, (01)00884838085350(21)175, (01)00884838085350(21)167, (01)00884838085350(21)78, (01)00884838085350(21)86, (01)00884838085350(21)91, (01)00884838085350(21)37, (01)00884838085350(21)72, (01)00884838085350(21)88, (01)00884838085350(21)27, (01)00884838085350(21)121, (01)00884838085350(21)179, (01)00884838085350(21)183, (01)00884838085350(21)117, (01)00884838085350(21)118, (01)00884838085350(21)85, (01)00884838085350(21)89, (01)00884838085350(21)90, (01)00884838085350(21)119, (01)00884838085350(21)87, (01)00884838085350(21)31, (01)00884838085350(21)110, (01)00884838085350(21)178, (01)00884838085350(21)73, (01)00884838085350(21)39, (01)00884838085350(21)56, (01)00884838085350(21)139, (01)00884838085350(21)61; 4. Azurion 7 B20
Model
722068
UDI
(01)00884838085367(21)178, (01)00884838085367(21)335, (01)00884838085367(21)147, (01)00884838085367(21)205, (01)00884838085367(21)170, (01)00884838085367(21)95 — +263 moreShow all
(01)00884838085367(21)178, (01)00884838085367(21)335, (01)00884838085367(21)147, (01)00884838085367(21)205, (01)00884838085367(21)170, (01)00884838085367(21)95, (01)00884838085367(21)440, (01)00884838085367(21)247, (01)00884838085367(21)225, (01)00884838085367(21)64, (01)00884838085367(21)149, (01)00884838085367(21)42, (01)00884838085367(21)324, (01)00884838085367(21)323, (01)00884838085367(21)320, (01)00884838085367(21)85, (01)00884838085367(21)89, (01)00884838085367(21)109, (01)00884838085367(21)239, (01)00884838085367(21)271, (01)00884838085367(21)104, (01)00884838085367(21)370, (01)00884838085367(21)322, (01)00884838085367(21)136, (01)00884838085367(21)373, (01)00884838085367(21)308, (01)00884838085367(21)354, (01)00884838085367(21)75, (01)00884838085367(21)279, (01)00884838085367(21)400, (01)00884838085367(21)196, (01)00884838085367(21)110, (01)00884838085367(21)78, (01)00884838085367(21)330, (01)00884838085367(21)73, (01)00884838085367(21)288, (01)00884838085367(21)285, (01)00884838085367(21)295, (01)00884838085367(21)329, (01)00884838085367(21)184, (01)00884838085367(21)350, (01)00884838085367(21)304, (01)00884838085367(21)319, (01)00884838085367(21)490, (01)00884838085367(21)243, (01)00884838085367(21)103, (01)00884838085367(21)262, (01)00884838085367(21)261, (01)00884838085367(21)277, (01)00884838085367(21)150, (01)00884838085367(21)172, (01)00884838085367(21)117, (01)00884838085367(21)356, (01)00884838085367(21)130, (01)00884838085367(21)146, (01)00884838085367(21)143, (01)00884838085367(21)84, (01)00884838085367(21)251, (01)00884838085367(21)361, (01)00884838085367(21)76, (01)00884838085367(21)270, (01)00884838085367(21)114, (01)00884838085367(21)232, (01)00884838085367(21)137, (01)00884838085367(21)107, (01)00884838085367(21)282, (01)00884838085367(21)337, (01)00884838085367(21)101, (01)00884838085367(21)213, (01)00884838085367(21)111, (01)00884838085367(21)82, (01)00884838085367(21)113, (01)00884838085367(21)275, (01)00884838085367(21)265, (01)00884838085367(21)459, (01)00884838085367(21)276, (01)00884838085367(21)62, (01)00884838085367(21)302, (01)00884838085367(21)88, (01)00884838085367(21)126, (01)00884838085367(21)211, (01)00884838085367(21)283, (01)00884838085367(21)231, (01)00884838085367(21)207, (01)00884838085367(21)167, (01)00884838085367(21)289, (01)00884838085367(21)233, (01)00884838085367(21)173, (01)00884838085367(21)204, (01)00884838085367(21)77, (01)00884838085367(21)313, (01)00884838085367(21)236, (01)00884838085367(21)237, (01)00884838085367(21)133, (01)00884838085367(21)280, (01)00884838085367(21)307, (01)00884838085367(21)210, (01)00884838085367(21)258, (01)00884838085367(21)328, (01)00884838085367(21)325, (01)00884838085367(21)199, (01)00884838085367(21)53, (01)00884838085367(21)364, (01)00884838085367(21)491, (01)00884838085367(21)246, (01)00884838085367(21)142, (01)00884838085367(21)257, (01)00884838085367(21)140, (01)00884838085367(21)369, (01)00884838085367(21)97, (01)00884838085367(21)87, (01)00884838085367(21)303, (01)00884838085367(21)48, (01)00884838085367(21)44, (01)00884838099272(21)809, (01)00884838085367(21)242, (01)00884838085367(21)238, (01)00884838085367(21)160, (01)00884838085367(21)83, (01)00884838085367(21)68, (01)00884838085367(21)230, (01)00884838085367(21)360, (01)00884838085367(21)93, (01)00884838085367(21)36, (01)00884838099272(21)4, (01)00884838085367(21)372, (01)00884838085367(21)179, (01)00884838085367(21)306, (01)00884838085367(21)182, (01)00884838085367(21)327, (01)00884838085367(21)244, (01)00884838085367(21)382, (01)00884838085367(21)192, (01)00884838085367(21)215, (01)00884838085367(21)399, (01)00884838085367(21)338, (01)00884838085367(21)339, (01)00884838085367(21)316, (01)00884838085367(21)134, (01)00884838085367(21)38, (01)00884838085367(21)158, (01)00884838085367(21)318, (01)00884838085367(21)250, (01)00884838085367(21)118, (01)00884838085367(21)336, (01)00884838085367(21)185, (01)00884838085367(21)206, (01)00884838085367(21)50, (01)00884838085367(21)489, (01)00884838085367(21)37, (01)00884838085367(21)79, (01)00884838085367(21)254, (01)00884838085367(21)394, (01)00884838085367(21)71, (01)00884838085367(21)47, (01)00884838085367(21)292, (01)00884838085367(21)35, (01)00884838085367(21)293, (01)00884838085367(21)227, (01)00884838085367(21)359, (01)00884838085367(21)387, (01)00884838085367(21)168, (01)00884838085367(21)128, (01)00884838085367(21)129, (01)00884838085367(21)69, (01)00884838085367(21)174, (01)00884838085367(21)483, (01)00884838085367(21)334, (01)00884838085367(21)181, (01)00884838085367(21)166, (01)00884838085367(21)141, (01)00884838085367(21)365, (01)00884838085367(21)198, (01)00884838085367(21)228, (01)00884838085367(21)380, (01)00884838085367(21)420, (01)00884838085367(21)212, (01)00884838085367(21)180, (01)00884838085367(21)268, (01)00884838085367(21)269, (01)00884838085367(21)74, (01)00884838085367(21)115, (01)00884838085367(21)349, (01)00884838085367(21)291, (01)00884838085367(21)234, 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(01)00884838085367(21)90, (01)00884838085367( …
Model
722078
UDI
(01)00884838085251(21)302, (01)00884838085251(21)585, (01)00884838085251(21)410, (01)00884838085251(21)523, (01)00884838085251(21)293, (01)00884838085251(21)291 — +493 moreShow all
(01)00884838085251(21)302, (01)00884838085251(21)585, (01)00884838085251(21)410, (01)00884838085251(21)523, (01)00884838085251(21)293, (01)00884838085251(21)291, (01)00884838085251(21)536, (01)00884838085251(21)537, (01)00884838085251(21)613, (01)00884838085251(21)598, (01)00884838085251(21)224, (01)00884838085251(21)249, (01)00884838085251(21)546, (01)00884838085251(21)478, (01)00884838085251(21)479, (01)00884838085251(21)513, (01)00884838085251(21)278, (01)00884838085251(21)438, (01)00884838085251(21)437, (01)00884838085251(21)456, (01)00884838085251(21)566, (01)00884838085251(21)488, (01)00884838085251(21)550, (01)00884838085251(21)571, (01)00884838085251(21)545, (01)00884838085251(21)544, (01)00884838085251(21)465, (01)00884838085251(21)376, (01)00884838085251(21)31, (01)00884838085251(21)165, (01)00884838085251(21)445, (01)00884838085251(21)539, (01)00884838085251(21)654, (01)00884838085251(21)656, (01)00884838085251(21)658, (01)00884838085251(21)657, (01)00884838085251(21)436, (01)00884838085251(21)308, (01)00884838085251(21)396, (01)00884838085251(21)576, (01)00884838085251(21)121, (01)00884838085251(21)383, (01)00884838085251(21)239, (01)00884838085251(21)491, (01)00884838085251(21)125, (01)00884838085251(21)500, (01)00884838085251(21)645, (01)00884838085251(21)379, (01)00884838085251(21)399, (01)00884838085251(21)415, (01)00884838085251(21)296, (01)00884838085251(21)136, (01)00884838085251(21)697, (01)00884838085251(21)626, (01)00884838085251(21)559, (01)00884838085251(21)532, (01)00884838085251(21)538, (01)00884838085251(21)185, (01)00884838085251(21)166, (01)00884838085251(21)257, (01)00884838085251(21)258, (01)00884838085251(21)359, (01)00884838085251(21)143, (01)00884838085251(21)661, (01)00884838085251(21)649, (01)00884838085251(21)493, (01)00884838085251(21)720, (01)00884838085251(21)520, (01)00884838085251(21)558, (01)00884838085251(21)521, (01)00884838085251(21)556, (01)00884838085251(21)557, (01)00884838085251(21)187, (01)00884838085251(21)360, 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(01)00884838085251(21)20, (01)00884838085251(21)625, (01)00884838085251(21)424, (01)00884838085251(21)590, (01)00884838085251(21)156, (01)00884838085251(21)150, (01)00884838085251(21)485, (01)00884838085251(21)727, (01)00884838085251(21)371, (01)00884838085251(21)572, (01)00884838085251(21)570, (01)00884838085251(21)196, (01)00884838085251(21)683, (01)00884838085251(21)541, (01)00884838085251(21)213, (01)00884838085251(21)651, (01)00884838085251(21)36, (01)00884838085251(21)431, (01)00884838085251(21)672, (01)00884838085251(21)177, (01)00884838085251(21)355, (01)00884838085251(21)504, (01)00884838085251(21)270, (01)00884838085251(21)306, (01)00884838085251(21)366, (01)00884838085251(21)52, (01)00884838085251(21)190, (01)00884838085251(21)398, (01)00884838085251(21)562, (01)00884838085251(21)470, (01)00884838085251(21)489, (01)00884838085251(21)147, (01)00884838085251(21)160, (01)00884838085251(21)152, (01)00884838085251(21)759, (01)00884838085251(21)630, (01)00884838085251(21)151, (01)0088483808 …
Show 4 more code fields
Model
722223
UDI
(01)00884838099241(21)61, (01)00884838099241(21)6, (01)00884838099241(21)12, (01)00884838099241(21)2; 7. Azurion 7 M20
Model
722079
UDI
(01)00884838085268(21)1023, (01)00884838085268(21)645, (01)00884838085268(21)646, (01)00884838085268(21)1013, (01)00884838085268(21)460, (01)00884838085268(21)43 — +78 moreShow all
(01)00884838085268(21)1023, (01)00884838085268(21)645, (01)00884838085268(21)646, (01)00884838085268(21)1013, (01)00884838085268(21)460, (01)00884838085268(21)43, (01)00884838085268(21)35, (01)00884838085268(21)890, (01)00884838085268(21)1137, (01)00884838085268(21)1048, (01)00884838085268(21)401, (01)00884838085268(21)1010, (01)00884838085268(21)1054, (01)00884838085268(21)536, (01)00884838085268(21)534, (01)00884838085268(21)535, (01)00884838085268(21)266, (01)00884838085268(21)818, (01)00884838085268(21)412, (01)00884838085268(21)617, (01)00884838085268(21)246, (01)00884838085268(21)488, (01)00884838085268(21)53, (01)00884838085268(21)57, (01)00884838085268(21)905, (01)00884838085268(21)55, (01)00884838085268(21)992, (01)00884838085268(21)691, (01)00884838085268(21)809, (01)00884838085268(21)848, (01)00884838085268(21)1033, (01)00884838085268(21)891, (01)00884838085268(21)836, (01)00884838085268(21)1155, (01)00884838085268(21)466, (01)00884838085268(21)1157, (01)00884838085268(21)263, (01)00884838085268(21)420, (01)00884838085268(21)673, (01)00884838085268(21)298, (01)00884838085268(21)297, (01)00884838085268(21)299, (01)00884838085268(21)564, (01)00884838085268(21)838, (01)00884838085268(21)1117, (01)00884838085268(21)1032, (01)00884838085268(21)820, (01)00884838085268(21)987, (01)00884838085268(21)47, (01)00884838085268(21)881, (01)00884838085268(21)774, (01)00884838085268(21)856, (01)00884838085268(21)922, (01)00884838085268(21)58, (01)00884838085268(21)471, (01)00884838085268(21)955, (01)00884838085268(21)755, (01)00884838085268(21)633, (01)00884838085268(21)296, (01)00884838085268(21)884, (01)00884838085268(21)574, (01)00884838085268(21)991, (01)00884838085268(21)842, (01)00884838085268(21)753, (01)00884838085268(21)840, (01)00884838085268(21)790, (01)00884838085268(21)481, (01)00884838085268(21)407, (01)00884838085268(21)408, (01)00884838085268(21)877, (01)00884838085268(21)590, (01)00884838085268(21)710, (01)00884838085268(21)713, (01)00884838085268(21)711, (01)00884838085268(21)709, (01)00884838085268(21)716, (01)00884838085268(21)1216, (01)00884838085268(21)483, (01)00884838085268(21)1098, (01)00884838085268(21)241, (01)00884838085268(21)1108, (01)00884838085268(21)863, (01)00884838085268(21)350, (01)0088483808
Additional code information

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What the firm is doing

On April 28, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this URGENT Medical Device Correction letter to all users of the system so that they are aware of the issue. 2. In case the affected system has been transferred to another organization, please send a copy of this URGENT Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 3. Keep this letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 4. If you experience the issue described in this letter, please report it to your local Philips representative. Actions planned by Philips IGT Systems to correct the issue Starting in Q1 2027, Philips will replace the deaeration hose in the CU3101 tube cooling unit in all affected systems. Your local Philips representative will contact you to schedule a visit to replace the deaeration hose once available.

DistributionShow details

Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Yemen;

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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