Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-1091-2026

Z-1091-2026 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best

Recall Details

Product Type
Devices
Report Date
January 21, 2026
Initiation Date
December 12, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,466 units

Product Description

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.

Reason for Recall

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine/United Arab Emirate, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Vietnam, Yemen.

Code Information

Software Versions: R2.1.10 and R2.2.10. 1. Model Number (UDI): 722063 ((01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)108, (01)00884838085275(21)153, (01)00884838085275(21)69, (01)00884838085275(21)154, (01)00884838085275(21)97, (01)00884838085275(21)137, (01)00884838085275(21)116, (01)00884838085275(21)127, (01)00884838085275(21)151, (01)00884838085275(21)148, (01)00884838085275(21)150, (01)00884838085275(21)146, (01)00884838085275(21)149, (01)00884838085275(21)123, (01)00884838085275(21)130, (01)00884838085275(21)143, (01)00884838085275(21)139, (01)00884838085275(21)144, (01)00884838085275(21)145, (01)00884838085275(21)141, (01)00884838085275(21)140, (01)00884838085275(21)135, (01)00884838085275(21)133, (01)00884838085275(21)107, (01)00884838085275(21)120, (01)00884838085275(21)129, (01)00884838085275(21)105, (01)00884838085275(21)110, (01)00884838085275(21)128, (01)00884838085275(21)119, (01)00884838085275(21)113, (01)00884838085275(21)43, (01)00884838085275(21)117, (01)00884838085275(21)115, (01)00884838085275(21)101, (01)00884838085275(21)94, (01)00884838085275(21)106, (01)00884838085275(21)103, (01)00884838085275(21)99, (01)00884838085275(21)102, (01)00884838085275(21)104, (01)00884838085275(21)100, (01)00884838085275(21)80, (01)00884838085275(21)81, (01)00884838085275(21)89, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)92, (01)00884838085275(21)75, (01)00884838085275(21)82, (01)00884838085275(21)87, (01)00884838085275(21)93, (01)00884838085275(21)85, (01)00884838085275(21)88, (01)00884838085275(21)79, (01)00884838085275(21)83, (01)00884838085275(21)76, (01)00884838085275(21)77, (01)00884838085275(21)78, (01)00884838085275(21)70, (01)00884838085275(21)53, (01)00884838085275(21)72, (01)00884838085275(21)63, (01)00884838085275(21)71, (01)00884838085275(21)73, (01)00884838085275(21)62, (01)00884838085275(21)50, (01)00884838085275(21)59, (01)00884838085275(21)54, (01)00884838085275(21)61, (01)00884838085275(21)52, (01)00884838085275(21)55, (01)00884838085275(21)40, (01)00884838085275(21)51, (01)00884838085275(21)48, (01)00884838085275(21)47, (01)00884838085275(21)46, (01)00884838085275(21)44, (01)00884838085275(21)41, (01)00884838085275(21)38, (01)00884838085275(21)29, (01)00884838085275(21)27, (01)00884838085275(21)28, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)26, (01)00884838085275(21)25, (01)00884838085275(21)30, (01)00884838085275(21)21, (01)00884838085275(21)24, (01)00884838085275(21)22, (01)00884838085275(21)19, (01)00884838085275(21)23, (01)00884838085275(21)18, (01)00884838085275(21)17, (01)00884838085275(21)15, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)3, (01)00884838085275(21)2, (01)00884838085275(21)4, (01)00884838085275(21)121), 722221 ((01)00884838099203(21)181, (01)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838099203(21)178, (01)00884838099203(21)54, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)177, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)171, (01)00884838099203(21)153, (01)00884838099203(21)108, (01)00884838099203(21)207, (01)00884838099203(21)208, (01)00884838099203(21)198, (01)00884838099203(21)193, (01)00884838099203(21)194, (01)00884838099203(21)205, (01)00884838099203(21)203, (01)00884838099203(21)202, (01)00884838099203(21)195, (01)00884838099203(21)196, (01)00884838099203(21)197, (01)00884838099203(21)190, (01)00884838099203(21)146, (01)00884838099203(21)186, (01)00884838099203(21)35, (01)00884838099203(21)43, (01)00884838099203(21)180, (01)00884838099203(21)187, (01)00884838099203(21)182, (01)00884838099203(21)185, (01)00884838099203(21)173, (01)00884838099203(21)183, (01)00884838099203(21)164, (01)00884838099203(21)184, (01)00884838099203(21)165, (01)00884838099203(21)176, (01)00884838099203(21)174, (01)00884838099203(21)159, (01)00884838099203(21)161, (01)00884838099203(21)157, (01)00884838099203(21)169, (01)00884838099203(21)162, (01)00884838099203(21)167, (01)00884838099203(21)168, (01)00884838099203(21)142, (01)00884838099203(21)145, (01)00884838099203(21)158, (01)00884838099203(21)166, (01)00884838099203(21)163, (01)00884838099203(21)149, (01)00884838099203(21)126, (01)00884838099203(21)154, (01)00884838099203(21)151, (01)00884838099203(21)127, (01)00884838099203(21)152, (01)00884838099203(21)155, (01)00884838099203(21)131, (01)00884838099203(21)147, (01)00884838099203(21)129, (01)00884838099203(21)122, (01)00884838099203(21)133, (01)00884838099203(21)144, (01)00884838099203(21)130, (01)00884838099203(21)143, (01)00884838099203(21)135, (01)00884838099203(21)140, (01)00884838099203(21)141, (01)00884838099203(21)128, (01)00884838099203(21)134, (01)00884838099203(21)132, (01)00884838099203(21)123, (01)00884838099203(21)118, (01)00884838099203(21)96, (01)00884838099203(21)120, (01)00884838099203(21)86, (01)00884838099203(21)124, (01)00884838099203(21)119, (01)00884838099203(21)107, (01)00884838099203(21)114, (01)00884838099203(21)98, (01)00884838099203(21)103, (01)00884838099203(21)74, (01)00884838099203(21)99, (01)00884838099203(21)81, (01)00884838099203(21)104, (01)00884838099203(21)106, (01)00884838099203(21)95, (01)00884838099203(21)102, (01)00884838099203(21)78, (01)00884838099203(21)97, (01)00884838099203(21)91, (01)00884838099203(21)66, (01)00884838099203(21)105, (01)00884838099203(21)101, (01)00884838099203(21)94, (01)00884838099203(21)52, (01)00884838099203(21)83, (01)00884838099203(21)84, (01)00884838099203(21)82, (01)00884838099203(21)64, (01)00884838099203(21)92, (01)00884838099203(21)55, (01)00884838099203(21)62, (01)00884838099203(21)79, (01)00884838099203(21)61, (01)00884838099203(21)71, (01)00884838099203(21)67, (01)00884838099203(21)77, (01)00884838099203(21)70, (01)00884838099203(21)76, (01)00884838099203(21)75, (01)00884838099203(21)73, (01)00884838099203(21)40, (01)00884838099203(21)68, (01)00884838099203(21)59, (01)00884838099203(21)33, (01)00884838099203(21)56, (01)00884838099203(21)44, (01)00884838099203(21)60, (01)00884838099203(21)58, (01)00884838099203(21)46, (01)00884838099203(21)57, (01)00884838099203(21)50, (01)00884838099203(21)51, (01)00884838099203(21)53, (01)00884838099203(21)32, (01)00884838099203(21)38, (01)00884838099203(21)48, (01)00884838099203(21)47, (01)00884838099203(21)45, (01)00884838099203(21)34, (01)00884838099203(21)36, (01)00884838099203(21)39, (01)00884838099203(21)31, (01)00884838099203(21)42, (01)00884838099203(21)41, (01)00884838099203(21)8, (01)00884838099203(21)30, (01)00884838099203(21)29, (01)00884838099203(21)27, (01)00884838099203(21)28, (01)00884838099203(21)22, (01)00884838099203(21)16, (01)00884838099203(21)26, (01)00884838099203(21)13, (01)00884838099203(21)25, (01)00884838099203(21)23, (01)00884838099203(21)10, (01)00884838099203(21)11, (01)00884838099203(21)15, (01)00884838099203(21)4, (01)00884838099203(21)5, (01)00884838099203(21)2, (01)00884838099203(21)1, (01)00884838099203(21)172). 2. Model Number (UDI): 722064 ((01)00884838085282(21)209, (01)00884838085282(21)238, (01)00884838085282(21)201, (01)00884838085282(21)258, (01)00884838085282(21)261, (01)00884838085282(21)260, (01)00884838085282(21)314, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)267, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)407, (01)00884838085282(21)496, (01)00884838085282(21)425, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)397, (01)00884838085282(21)168, (01)00884838085282(21)514, (01)00884838085282(21)503, (01)00884838085282(21)517, (01)00884838085282(21)515, (01)00884838085282(21)478, (01)00884838085282(21)484, (01)00884838085282(21)511, (01)00884838085282(21)458, (01)00884838085282(21)513, (01)00884838085282(21)505, (01)00884838085282(21)502, (01)00884838085282(21)510, (01)00884838085282(21)508, (01)00884838085282(21)470, (01)00884838085282(21)509, (01)00884838085282(21)494, (01)00884838085282(21)497, (01)00884838085282(21)477, (01)00884838085282(21)445, (01)00884838085282(21)448, (01)00884838085282(21)500, (01)00884838085282(21)501, (01)00884838085282(21)471, (01)00884838085282(21)491, (01)00884838085282(21)498, (01)00884838085282(21)490, (01)00884838085282(21)475, (01)00884838085282(21)480, (01)00884838085282(21)504, (01)00884838085282(21)479, (01)00884838085282(21)488, (01)00884838085282(21)395, (01)00884838085282(21)485, (01)00884838085282(21)474, (01)00884838085282(21)476, (01)00884838085282(21)483, (01)00884838085282(21)468, (01)00884838085282(21)492, (01)00884838085282(21)473, (01)00884838085282(21)472, (01)00884838085282(21)467, (01)00884838085282(21)461, (01)00884838085282(21)469, (01)00884838085282(21)462, (01)00884838085282(21)446, (01)00884838085282(21)463, (01)00884838085282(21)447, (01)00884838085282(21)451, (01)00884838085282(21)454, (01)00884838085282(21)457, (01)00884838085282(21)427, (01)00884838085282(21)345, 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(01)00884838103276(21)141, (01)00884838103276(21)87, (01)00884838103276(21)59, (01)00884838103276(21)126, (01)00884838103276(21)112, (01)00884838103276(21)125, (01)00884838103276(21)124, (01)00884838103276(21)123, (01)00884838103276(21)84, (01)00884838103276(21)137, (01)00884838103276(21)96, (01)00884838103276(21)135, (01)00884838103276(21)53, (01)00884838103276(21)57, (01)00884838103276(21)107, (01)00884838103276(21)103, (01)00884838103276(21)127, (01)00884838103276(21)129, (01)00884838103276(21)131, (01)00884838103276(21)120, (01)00884838103276(21)108, (01)00884838103276(21)83, (01)00884838103276(21)101, (01)00884838103276(21)118, (01)00884838103276(21)54, (01)00884838103276(21)105, (01)00884838103276(21)128, (01)00884838103276(21)100, (01)00884838103276(21)63, (01)00884838103276(21)98, (01)00884838103276(21)114, (01)00884838103276(21)119, (01)00884838103276(21)52, (01)00884838103276(21)69, (01)00884838103276(21)40, (01)00884838103276(21)74, (01)00884838103276(21)45, (01)00884838103276(21)39, (01)00884838103276(21)88, (01)00884838103276(21)41, (01)00884838103276(21)91, (01)00884838103276(21)81, (01)00884838103276(21)44, (01)00884838103276(21)93, (01)00884838103276(21)58, (01)00884838103276(21)80, (01)00884838103276(21)82, (01)00884838103276(21)94, (01)00884838103276(21)46, (01)00884838103276(21)43, (01)00884838103276(21)76, (01)00884838103276(21)42, (01)00884838103276(21)60, (01)00884838103276(21)38, (01)00884838103276(21)37, (01)00884838103276(21)20, (01)00884838103276(21)36, (01)00884838103276(21)34, (01)00884838103276(21)35, (01)00884838103276(21)23, (01)00884838103276(21)33, (01)00884838103276(21)19, (01)00884838103276(21)22, (01)00884838103276(21)24, (01)00884838103276(21)21, (01)00884838103276(21)17, (01)00884838103276(21)65, (01)00884838103276(21)30, (01)00884838103276(21)106). 3. Model Number (UDI): 722227 ((01)00884838099227(21)265, (01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)276, (01)00884838099227(21)264, (01)00884838099227(21)63, (01)00884838099227(21)238, (01)00884838099227(21)360, (01)00884838099227(21)322, (01)00884838099227(21)336, (01)00884838099227(21)356, (01)00884838099227(21)353, (01)00884838099227(21)342, (01)00884838099227(21)338, (01)00884838099227(21)345, (01)00884838099227(21)344, (01)00884838099227(21)284, (01)00884838099227(21)326, (01)00884838099227(21)362, (01)00884838099227(21)351, (01)00884838099227(21)208, (01)00884838099227(21)340, (01)00884838099227(21)348, (01)00884838099227(21)352, (01)00884838099227(21)306, (01)00884838099227(21)335, (01)00884838099227(21)332, (01)00884838099227(21)350, (01)00884838099227(21)331, (01)00884838099227(21)355, (01)00884838099227(21)330, (01)00884838099227(21)334, (01)00884838099227(21)346, (01)00884838099227(21)333, (01)00884838099227(21)297, (01)00884838099227(21)339, (01)00884838099227(21)337, (01)00884838099227(21)324, (01)00884838099227(21)321, (01)00884838099227(21)101, (01)00884838099227(21)313, (01)00884838099227(21)89, (01)00884838099227(21)323, (01)00884838099227(21)329, (01)00884838099227(21)318, (01)00884838099227(21)319, (01)00884838099227(21)175, (01)00884838099227(21)311, (01)00884838099227(21)320, (01)00884838099227(21)308, (01)00884838099227(21)301, (01)00884838099227(21)247, (01)00884838099227(21)315, (01)00884838099227(21)305, (01)00884838099227(21)316, (01)00884838099227(21)272, (01)00884838099227(21)286, (01)00884838099227(21)258, (01)00884838099227(21)300, (01)00884838099227(21)307, (01)00884838099227(21)280, (01)00884838099227(21)294, (01)00884838099227(21)178, (01)00884838099227(21)298, (01)00884838099227(21)253, (01)00884838099227(21)309, (01)00884838099227(21)310, (01)00884838099227(21)304, (01)00884838099227(21)293, (01)00884838099227(21)269, (01)00884838099227(21)260, (01)00884838099227(21)292, (01)00884838099227(21)299, (01)00884838099227(21)230, (01)00884838099227(21)252, (01)00884838099227(21)285, (01)00884838099227(21)102, (01)00884838099227(21)287, (01)00884838099227(21)282, (01)00884838099227(21)273, (01)00884838099227(21)251, (01)00884838099227(21)268, (01)00884838099227(21)290, (01)00884838099227(21)206, (01)00884838099227(21)281, (01)00884838099227(21)263, (01)00884838099227(21)262, (01)00884838099227(21)250, (01)00884838099227(21)261, (01)00884838099227(21)270, (01)00884838099227(21)156, (01)00884838099227(21)213, (01)00884838099227(21)245, (01)00884838099227(21)241, (01)00884838099227(21)259, (01)00884838099227(21)228, (01)00884838099227(21)157, (01)00884838099227(21)256, (01)00884838099227(21)249, (01)00884838099227(21)243, (01)00884838099227(21)209, (01)00884838099227(21)180, (01)00884838099227(21)158, (01)00884838099227(21)227, (01)00884838099227(21)176, (01)00884838099227(21)236, (01)00884838099227(21)240, (01)00884838099227(21)233, (01)00884838099227(21)203, (01)00884838099227(21)248, (01)00884838099227(21)217, (01)00884838099227(21)246, (01)00884838099227(21)257, (01)00884838099227(21)242, (01)00884838099227(21)173, (01)00884838099227(21)234, (01)00884838099227(21)231, (01)00884838099227(21)239, (01)00884838099227(21)181, (01)00884838099227(21)216, (01)00884838099227(21)229, (01)00884838099227(21)222, (01)00884838099227(21)211, (01)00884838099227(21)218, (01)00884838099227(21)215, (01)00884838099227(21)219, (01)00884838099227(21)221, (01)00884838099227(21)220, (01)00884838099227(21)188, (01)00884838099227(21)95, (01)00884838099227(21)205, (01)00884838099227(21)87, (01)00884838099227(21)147, (01)00884838099227(21)204, (01)00884838099227(21)200, (01)00884838099227(21)196, (01)00884838099227(21)194, (01)00884838099227(21)210, (01)00884838099227(21)192, (01)00884838099227(21)187, (01)00884838099227(21)177, (01)00884838099227(21)202, (01)00884838099227(21)198, (01)00884838099227(21)195, (01)00884838099227(21)197, (01)00884838099227(21)199, (01)00884838099227(21)151, (01)00884838099227(21)183, (01)00884838099227(21)191, (01)00884838099227(21)174, (01)00884838099227(21)86, (01)00884838099227(21)179, (01)00884838099227(21)146, (01)00884838099227(21)123, (01)00884838099227(21)140, (01)00884838099227(21)184, (01)00884838099227(21)161, (01)00884838099227(21)145, (01)00884838099227(21)153, (01)00884838099227(21)170, (01)00884838099227(21)172, (01)00884838099227(21)168, (01)00884838099227(21)82, (01)00884838099227(21)163, (01)00884838099227(21)154, (01)00884838099227(21)155, (01)00884838099227(21)159, (01)00884838099227(21)167, (01)00884838099227(21)164, (01)0088

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