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RecallWatchMedical Device Safety
Class IIOngoingZ-2225-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems not configured with an optional auxiliary pan handle. Includes…

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

Reason for recall

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.

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.

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.

Lot / code information

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 — +66 moreShow all
]: 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
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 — +605 moreShow all
]: 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, 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(01)00884838085282(21)269, (01)00884838085282(21)111, (01)00884838085282(21)11, (01)00884838085282(21)509, (01)00884838085282(21)454, (01)00884838085282(21)478, (01)00884838085282(21)262, (01)00884838085282(21)491, (01)00884838085282(21)337, (01)00884838085282(21)468, (01)00884838085282(21)412, (01)00884838085282(21)414, (01)00884838085282(21)405, (01)00884838085282(21)396, (01)00884838085282(21)247, (01)00884838085282(21)443, (01)00884838085282(21)310, (01)00884838085282(21)406, (01)00884838085282(21)517, (01)00884838085282(21)432, (01)00884838085282(21)504, (01)00884838085282(21)457, (01)00884838085282(21)426, (01)00884838085282(21)304, (01)00884838085282(21)469, (01)00884838085282(21)340, (01)00884838085282(21)393, (01)00884838085282(21)343, (01)00884838085282(21)458, (01)00884838085282(21)322, (01)00884838085282(21)444, (01)00884838085282(21)508, (01)00884838085282(21)445, (01)00884838085282(21)395, (01)00884838085282(21)385, (01)00884838085282(21)505, (01)00884838085282(21)472, 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(01)00884838085282(21)174, (01)00884838085282(21)165, (01)00884838085282(21)452, (01)00884838085282(21)447, (01)00884838085282(21)148, (01)00884838085282(21)182, (01)00884838085282(21)112, (01)00884838085282(21)302, (01)00884838085282(21)86, (01)00884838085282(21)317, (01)00884838085282(21)198, (01)00884838085282(21)378, (01)00884838085282(21)206, (01)00884838085282(21)136, (01)00884838085282(21)312, (01)00884838085282(21)143, (01)00884838085282(21)403, (01)00884838085282(21)386, (01)00884838085282(21)397, (01)00884838085282(21)500, (01)00884838085282(21)226, (01)00884838085282(21)408, (01)00884838085282(21)381, (01)00884838085282(21)488, (01)00884838085282(21)416, (01)00884838085282(21)80, (01)00884838085282(21)12, (01)00884838085282(21)404, (01)00884838085282(21)285, (01)00884838085282(21)515, (01)00884838085282(21)476, (01)00884838085282(21)449, (01)00884838085282(21)477, (01)00884838085282(21)338, (01)00884838085282(21)419, (01)00884838085282(21)215, (01)00884838085282(21)164, (01)00884838085282(21)434, (01)00884838085282(21)114, …
UDI
]: 722227 [(01)00884838099227(21)159, (01)00884838099227(21)197, (01)00884838099227(21)149, (01)00884838099227(21)54, (01)00884838099227(21)56, (01)00884838099227(21)230 — +190 moreShow all
]: 722227 [(01)00884838099227(21)159, (01)00884838099227(21)197, (01)00884838099227(21)149, (01)00884838099227(21)54, (01)00884838099227(21)56, (01)00884838099227(21)230, (01)00884838099227(21)98, (01)00884838099227(21)31, (01)00884838099227(21)128, (01)00884838099227(21)81, (01)00884838099227(21)37, (01)00884838099227(21)320, (01)00884838099227(21)53, (01)00884838099227(21)246, (01)00884838099227(21)245, (01)00884838099227(21)84, (01)00884838099227(21)38, (01)00884838099227(21)28, (01)00884838099227(21)29, (01)00884838099227(21)170, (01)00884838099227(21)30, (01)00884838099227(21)108, (01)00884838099227(21)168, (01)00884838099227(21)172, (01)00884838099227(21)62, (01)00884838099227(21)236, (01)00884838099227(21)104, (01)00884838099227(21)59, (01)00884838099227(21)109, (01)00884838099227(21)101, (01)00884838099227(21)99, (01)00884838099227(21)247, (01)00884838099227(21)177, (01)00884838099227(21)138, (01)00884838099227(21)337, (01)00884838099227(21)61, (01)00884838099227(21)287, (01)00884838099227(21)55, (01)00884838099227(21)215, (01)00884838099227(21)216, (01)00884838099227(21)73, (01)00884838099227(21)318, (01)00884838099227(21)167, (01)00884838099227(21)85, (01)00884838099227(21)191, (01)00884838099227(21)20, (01)00884838099227(21)226, (01)00884838099227(21)83, (01)00884838099227(21)218, (01)00884838099227(21)195, (01)00884838099227(21)43, (01)00884838099227(21)18, (01)00884838099227(21)153, (01)00884838099227(21)351, (01)00884838099227(21)352, (01)00884838099227(21)120, (01)00884838099227(21)204, (01)00884838099227(21)258, (01)00884838099227(21)326, (01)00884838099227(21)348, (01)00884838099227(21)17, (01)00884838099227(21)141, (01)00884838099227(21)103, (01)00884838099227(21)355, (01)00884838099227(21)113, (01)00884838099227(21)315, (01)00884838099227(21)161, (01)00884838099227(21)194, (01)00884838099227(21)105, (01)00884838099227(21)171, (01)00884838099227(21)49, (01)00884838099227(21)71, (01)00884838099227(21)91, (01)00884838099227(21)187, (01)00884838099227(21)166, (01)00884838099227(21)210, (01)00884838099227(21)219, (01)00884838099227(21)222, (01)00884838099227(21)273, (01)00884838099227(21)205, (01)00884838099227(21)300, (01)00884838099227(21)335, (01)00884838099227(21)80, (01)00884838099227(21)123, (01)00884838099227(21)243, (01)00884838099227(21)344, (01)00884838099227(21)308, (01)00884838099227(21)22, (01)00884838099227(21)140, (01)00884838099227(21)362, (01)00884838099227(21)242, (01)00884838099227(21)323, (01)00884838099227(21)331, (01)00884838099227(21)136, (01)00884838099227(21)137, (01)00884838099227(21)89, (01)00884838099227(21)294, (01)00884838099227(21)2, (01)00884838099227(21)111, (01)00884838099227(21)221, (01)00884838099227(21)165, (01)00884838099227(21)1, (01)00884838099227(21)16, (01)00884838099227(21)12, (01)00884838099227(21)257, (01)00884838099227(21)330, (01)00884838099227(21)67, (01)00884838099227(21)260, (01)00884838099227(21)148, (01)00884838099227(21)281, (01)00884838099227(21)248, (01)00884838099227(21)333, (01)00884838099227(21)199, (01)00884838099227(21)183, (01)00884838099227(21)106, (01)00884838099227(21)253, (01)00884838099227(21)52, (01)00884838099227(21)26, (01)00884838099227(21)233, (01)00884838099227(21)301, (01)00884838099227(21)211, (01)00884838099227(21)154, (01)00884838099227(21)217, (01)00884838099227(21)332, (01)00884838099227(21)44, (01)00884838099227(21)198, (01)00884838099227(21)297, (01)00884838099227(21)206, (01)00884838099227(21)292, (01)00884838099227(21)58, (01)00884838099227(21)130, (01)00884838099227(21)203, (01)00884838099227(21)107, (01)00884838099227(21)93, (01)00884838099227(21)125, (01)00884838099227(21)240, (01)00884838099227(21)122, (01)00884838099227(21)118, (01)00884838099227(21)46, (01)00884838099227(21)252, (01)00884838099227(21)184, (01)00884838099227(21)57, (01)00884838099227(21)202, (01)00884838099227(21)100, (01)00884838099227(21)115, (01)00884838099227(21)133, (01)00884838099227(21)350, (01)00884838099227(21)175, (01)00884838099227(21)229, (01)00884838099227(21)304, (01)00884838099227(21)124, (01)00884838099227(21)220, (01)00884838099227(21)79, (01)00884838099227(21)60, (01)00884838099227(21)311, (01)00884838099227(21)147, (01)00884838099227(21)146, (01)00884838099227(21)319, (01)00884838099227(21)74, (01)00884838099227(21)188, (01)00884838099227(21)9, (01)00884838099227(21)8, (01)00884838099227(21)94, (01)00884838099227(21)82, (01)00884838099227(21)86, (01)00884838099227(21)286, (01)00884838099227(21)96, (01)00884838099227(21)227, (01)00884838099227(21)231, (01)00884838099227(21)126, (01)00884838099227(21)162, (01)00884838099227(21)299, (01)00884838099227(21)35, (01)00884838099227(21)11, (01)00884838099227(21)259, (01)00884838099227(21)180, (01)00884838099227(21)160, (01)00884838099227(21)196, (01)00884838099227(21)208, (01)00884838099227(21)282, (01)00884838099227(21)13, (01)00884838099227(21)132, (01)00884838099227(21)209]; 722231 [(01)00884838116740(21)49, (01)00884838116740(21)21, (01)00884838116740(21)34, (01)00884838116740(21)61, (01)00884838116740(21)26, (01)00884838116740(21)28, (01)00884838116740(21)45, (01)00884838116740(21)20, (01)00884838116740(21)51, (01)00884838116740(21)29, (01)00884838116740(21)27, (01)00884838116740(21)35, (01)00884838116740(21)54, (01)00884838116740(21)32]. 4
UDI
]: 722228 [(01)00884838099234(21)328, (01)00884838099234(21)522, (01)00884838099234(21)187, (01)00884838099234(21)113, (01)00884838099234(21)205, (01)00884838099234(21)567 — +323 moreShow all
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(01)00884838099234(21)376, (01)0088483809923 …
Additional code information

0884838099234(21)294, (01)00884838099234(21)146, (01)00884838099234(21)175, (01)00884838099234(21)170, (01)00884838099234(21)295, (01)00884838099234(21)637, (01)00884838099234(21)290, (01)00884838099234(21)134, (01)00884838099234(21)136, (01)00884838099234(21)658, (01)00884838099234(21)289, (01)00884838099234(21)207, (01)00884838099234(21)686, (01)00884838099234(21)492, (01)00884838099234(21)119]; 722232 [(01)00884838116757(21)69, (01)00884838116757(21)3, (01)00884838116757(21)44, (01)00884838116757(21)37, (01)00884838116757(21)1, (01)00884838116757(21)11, (01)00884838116757(21)77, (01)00884838116757(21)71, (01)00884838116757(21)72, (01)00884838116757(21)70, (01)00884838116757(21)320, (01)00884838116757(21)167, (01)00884838116757(21)81, (01)00884838116757(21)35, (01)00884838116757(21)28, (01)00884838116757(21)30, (01)00884838116757(21)102, (01)00884838116757(21)19, (01)00884838116757(21)29, (01)00884838116757(21)56, (01)00884838116757(21)51, (01)00884838116757(21)73]; 722281 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(01)00884838110564(21)139, (01)00884838110564(21)408, (01)00884838110564(21)455, (01)00884838110564(21)173, (01)00884838110564(21)143, (01)00884838110564(21)29, (01)00884838110564(21)239, (01)00884838110564(21)15, (01)00884838110564(21)163, (01)00884838110564(21)437, (01)00884838110564(21)111, (01)00884838110564(21)252, (01)00884838110564(21)230, (01)00884838110564(21)42, (01)00884838110564(21)220, (01)00884838110564(21)213, (01)00884838110564(21)346, (01)00884838110564(21)347, (01)00884838110564(21)411, (01)00884838110564(21)362, (01)00884838110564(21)184, (01)00884838110564(21)185, (01)00884838110564(21)31, (01)00884838110564(21)30, (01)00884838110564(21)25, (01)00884838110564(21)106, (01)00884838110564(21)142, (01)00884838110564(21)128, (01)00884838110564(21)36, (01)00884838110564(21)84, (01)00884838110564(21)16, (01)00884838110564(21)431, (01)00884838110564(21)475, (01)00884838110564(21)257, (01)00884838110564(21)243, (01)00884838110564(21)241, (01)00884838110564(21)262, (01)00884838110564(21)165, (01)00884838110564(21)464, (01)00884838110564(21)147, (01)00884838110564(21)248, (01)00884838110564(21)288]. 5. Model Number [UDI]: 722067 [(01)00884838085350(21)128, (01)00884838085350(21)270, (01)00884838085350(21)251, (01)00884838085350(21)222, (01)00884838085350(21)262, (01)00884838085350(21)274, (01)00884838085350(21)218, (01)00884838085350(21)275, (01)00884838085350(21)127, (01)00884838085350(21)211, (01)00884838085350(21)212, (01)00884838085350(21)213, (01)00884838085350(21)210, (01)00884838085350(21)138, (01)00884838085350(21)254, (01)00884838085350(21)142, (01)00884838085350(21)60, (01)00884838085350(21)97, (01)00884838085350(21)45, (01)00884838085350(21)112, (01)00884838085350(21)134, (01)00884838085350(21)101, (01)00884838085350(21)100, (01)00884838085350(21)168, (01)00884838085350(21)235, (01)00884838085350(21)273, (01)00884838085350(21)176, (01)00884838085350(21)156, (01)00884838085350(21)276, (01)00884838085350(21)165, (01)00884838085350(21)25, (01)00884838085350(21)35, (01)00884838085350(21)202, (01)00884838085350(21)32, (01)00884838085350(21)38, (01)00884838085350(21)87, (01)00884838085350(21)56]; 722225 [(01)00884838099265(21)455, (01)00884838099265(21)284, (01)00884838099265(21)251, (01)00884838099265(21)468, (01)00884838099265(21)232, (01)00884838099265(21)230, (01)00884838099265(21)269, (01)00884838099265(21)345, (01)00884838099265(21)374, (01)00884838099265(21)241, (01)00884838099265(21)431, (01)00884838099265(21)450, (01)00884838099265(21)152, (01)00884838099265(21)145, (01)00884838099265(21)306, (01)00884838099265(21)140, (01)00884838099265(21)457, (01)00884838099265(21)314, (01)00884838099265(21)421, (01)00884838099265(21)422, (01)00884838099265(21)158, (01)00884838099265(21)267, (01)00884838099265(21)454, (01)00884838099265(21)438, (01)00884838099265(21)366, (01)00884838099265(21)173, (01)00884838099265(21)146, (01)00884838099265(21)196, (01)00884838099265(21)372, (01)00884838099265(21)254, (01)00884838099265(21)343, (01)00884838099265(21)201, (01)00884838099265(21)350, (01)00884838099265(21)373, (01)0088483809 …

What the firm is doing

Philips Medical notified consignees on about 04/28/2026 via certified mailed letter titled "URGENT Medical Device Correction." Consignees were made aware of the issue and instructed to circulate the notification to all users of the system for awareness, that affected systems may continue to be used in accordance with their Instructions for Use (IFU), if the required position cannot be achieved using the Float Tabletop control for table movement, use alternative system movements (e.g., stand movement) where clinically feasible to adjust the relative position between the system and the patient, and avoid contact with sharp edges in the event that the Float Tabletop control is damaged. Consignees were also instructed to maintain the notification letter with the documentation of the system until Philips corrects the system, ensure the notification is located where it can be viewed, notify customers if system has been transferred, and complete and return the provided Response Form. Philips will install an auxiliary pan handle on all affected systems. A Philips representative will contact consignees to schedule the implementation of this correction. Philips expects to begin implementation of the correction by July 2026.

DistributionShow details

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

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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