--- title: "Philips Azurion Systems R3.0. Includes the following label descriptions and c... — FDA record Z-1079-2026 | Is It on Recall" description: "Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the" url: https://isitonrecall.com/recall/fda-device-z-1079-2026-philips-azurion-systems-r3-0-includes-the-following-label-descriptions-and-corresponding-models-1-az/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M... — FDA record Z-1079-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Dec 8, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234. - **Reason**: Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error. - **Classification**: Class II - **Recalling firm**: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - **Quantity**: 990 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1079-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1079-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Software Version: R3.0. 1. Model Number: 722229. UDI Numbers: (01)00884838116726(21)22, (01)00884838116726(21)15, (01)00884838116726(21)16, (01)00884838116726(21)6, (01)00884838116726(21)8, (01)00884838116726(21)4, (01)00884838116726(21)24, (01)00884838116726(21)26, (01)00884838116726(21)20, (01)00884838116726(21)25, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13, (01)00884838116726(21)7, (01)00884838116726(21)10, (01)00884838116726(21)2, (01)00884838116726(21)3, (01)00884838116726(21)29. 2. Model Number: 722230. UDI Numbers: (01)00884838116733(21)2, (01)00884838116733(21)40, (01)00884838116733(21)9, (01)00884838116733(21)1, (01)00884838116733(21)38, (01)00884838116733(21)10, (01)00884838116733(21)45, (01)00884838116733(21)7, (01)00884838116733(21)27, (01)00884838116733(21)28, (01)00884838116733(21)39, (01)00884838116733(21)4, (01)00884838116733(21)5, (01)00884838116733(21)23, (01)00884838116733(21)41, (01)00884838116733(21)20, (01)00884838116733(21)19, (01)00884838116733(21)13, (01)00884838116733(21)15, (01)00884838116733(21)12, (01)00884838116733(21)22. 3. Model Number: 722231. UDI Numbers: (01)00884838116740(21)13, (01)00884838116740(21)29, (01)00884838116740(21)50, (01)00884838116740(21)21, (01)00884838116740(21)19, (01)00884838116740(21)12, (01)00884838116740(21)25, (01)00884838116740(21)4, (01)00884838116740(21)1, (01)00884838116740(21)5, (01)00884838116740(21)2, (01)00884838116740(21)73, (01)00884838116740(21)72, (01)00884838116740(21)75, (01)00884838116740(21)33, (01)00884838116740(21)47, (01)00884838116740(21)60, (01)00884838116740(21)53, (01)00884838116740(21)45, (01)00884838116740(21)61, (01)00884838116740(21)34, (01)00884838116740(21)54, (01)00884838116740(21)35, (01)00884838116740(21)49, (01)00884838116740(21)32, (01)00884838116740(21)28, (01)00884838116740(21)27, (01)00884838116740(21)26, (01)00884838116740(21)51, (01)00884838116740(21)11, (01)00884838116740(21)20, (01)00884838116740(21)41, (01)00884838116740(21)52, (01)00884838116740(21)3. 4. Model Number: 722232. UDI Numbers: (01)00884838116757(21)61, (01)00884838116757(21)60, (01)00884838116757(21)5, (01)00884838116757(21)49, (01)00884838116757(21)2, (01)00884838116757(21)91, (01)00884838116757(21)33, (01)00884838116757(21)34, (01)00884838116757(21)48, (01)00884838116757(21)46, (01)00884838116757(21)23, (01)00884838116757(21)43, (01)00884838116757(21)36, (01)00884838116757(21)96, (01)00884838116757(21)95, (01)00884838116757(21)10, (01)00884838116757(21)76, (01)00884838116757(21)42, (01)00884838116757(21)6, (01)00884838116757(21)77, (01)00884838116757(21)3, (01)00884838116757(21)1, (01)00884838116757(21)56, (01)00884838116757(21)51, (01)00884838116757(21)44, (01)00884838116757(21)30, (01)00884838116757(21)29, (01)00884838116757(21)28, (01)00884838116757(21)102, (01)00884838116757(21)19, (01)00884838116757(21)8, (01)00884838116757(21)81, (01)00884838116757(21)20, (01)00884838116757(21)16, (01)00884838116757(21)11, (01)00884838116757(21)112, (01)00884838116757(21)63, (01)00884838116757(21)68, (01)00884838116757(21)32, (01)00884838116757(21)35, (01)00884838116757(21)122, (01)00884838116757(21)14, (01)00884838116757(21)82, (01)00884838116757(21)13, (01)00884838116757(21)50, (01)00884838116757(21)57, (01)00884838116757(21)58, (01)00884838116757(21)4, (01)00884838116757(21)105, (01)00884838116757(21)75, (01)00884838116757(21)121, (01)00884838116757(21)120, (01)00884838116757(21)71, (01)00884838116757(21)72, (01)00884838116757(21)73, (01)00884838116757(21)70, (01)00884838116757(21)69, (01)00884838116757(21)37. 5. Model Number: 722235. UDI Numbers: (01)00884838116788(21)88, (01)00884838116788(21)43, (01)00884838116788(21)12, (01)00884838116788(21)102, (01)00884838116788(21)127, (01)00884838116788(21)57, (01)00884838116788(21)55, (01)00884838116788(21)11, (01)00884838116788(21)76, (01)00884838116788(21)71, (01)00884838116788(21)59, (01)00884838116788(21)77, (01)00884838116788(21)89, (01)00884838116788(21)56, (01)00884838116788(21)99, (01)00884838116788(21)30, (01)00884838116788(21)84, (01)00884838116788(21)82, (01)00884838116788(21)83, (01)00884838116788(21)93, (01)00884838116788(21)31, (01)00884838116788(21)47, (01)00884838116788(21)3, (01)00884838116788(21)13, (01)00884838116788(21)10, (01)00884838116788(21)74, (01)00884838116788(21)98, (01)00884838116788(21)40, (01)00884838116788(21)81, (01)00884838116788(21)66, (01)00884838116788(21)63, (01)00884838116788(21)67, (01)00884838116788(21)64, (01)00884838116788(21)42, (01)00884838116788(21)65, (01)00884838116788(21)58, (01)00884838116788(21)53, (01)00884838116788(21)52, (01)00884838116788(21)49, (01)00884838116788(21)44, (01)00884838116788(21)35, (01)00884838116788(21)45, (01)00884838116788(21)39, (01)00884838116788(21)25, (01)00884838116788(21)34, (01)00884838116788(21)17, (01)00884838116788(21)24, (01)00884838116788(21)19, (01)00884838116788(21)33, (01)00884838116788(21)18, (01)00884838116788(21)9, (01)00884838116788(21)28, (01)00884838116788(21)8, (01)00884838116788(21)23, (01)00884838116788(21)21, (01)00884838116788(21)6, (01)00884838116788(21)7, (01)00884838116788(21)5, (01)00884838116788(21)108, (01)00884838116788(21)109, (01)00884838116788(21)107, (01)00884838116788(21)106, (01)00884838116788(21)4, (01)00884838116788(21)41, (01)00884838116788(21)72, (01)00884838116788(21)70, (01)00884838116788(21)54, (01)00884838116788(21)20, (01)00884838116788(21)14, (01)00884838116788(21)126, (01)00884838116788(21)105, (01)00884838116788(21)94. 6. Model Number: 722236. UDI Numbers: (01)00884838116801(21)43, (01)00884838116801(21)42, (01)00884838116801(21)121, (01)00884838116801(21)50, (01)00884838116801(21)183, (01)00884838116801(21)32, (01)00884838116801(21)38, (01)00884838116801(21)197, (01)00884838116801(21)335, (01)00884838116801(21)325, (01)00884838116801(21)116, (01)00884838116801(21)191, (01)00884838116801(21)235, (01)00884838116801(21)22, (01)00884838116801(21)204, (01)00884838116801(21)249, (01)00884838116801(21)159, (01)00884838116801(21)40, (01)00884838116801(21)233, (01)00884838116801(21)194, (01)00884838116801(21)205, (01)00884838116801(21)276, (01)00884838116801(21)378, (01)00884838116801(21)20, (01)00884838116801(21)81, (01)00884838116801(21)51, (01)00884838116801(21)288, (01)00884838116801(21)25, (01)00884838116801(21)54, (01)00884838116801(21)186, (01)00884838116801(21)21, (01)00884838116801(21)68, (01)00884838116801(21)99, (01)00884838116801(21)208, (01)00884838116801(21)31, (01)00884838116801(21)230, (01)00884838116801(21)203, (01)00884838116801(21)180, (01)00884838116801(21)37, (01)00884838116801(21)342, (01)00884838116801(21)24, (01)00884838116801(21)221, (01)00884838116801(21)17, (01)00884838116801(21)252, (01)00884838116801(21)150, (01)00884838116801(21)60, (01)00884838116801(21)200, (01)00884838116801(21)226, (01)00884838116801(21)118, (01)00884838116801(21)127, (01)00884838116801(21)26, (01)00884838116801(21)36, (01)00884838116801(21)133, (01)00884838116801(21)345, (01)00884838116801(21)134, (01)00884838116801(21)131, (01)00884838116801(21)39, (01)00884838116801(21)231, (01)00884838116801(21)158, (01)00884838116801(21)48, (01)00884838116801(21)227, (01)00884838116801(21)148, (01)00884838116801(21)147, (01)00884838116801(21)272, (01)00884838116801(21)273, (01)00884838116801(21)100, (01)00884838116801(21)224, (01)00884838116801(21)164, (01)00884838116801(21)163, (01)00884838116801(21)170, (01)00884838116801(21)44, (01)00884838116801(21)46, (01)00884838116801(21)113, (01)00884838116801(21)216, (01)00884838116801(21)278, (01)00884838116801(21)102, (01)00884838116801(21)8, (01)00884838116801(21)169, (01)00884838116801(21)338, (01)00884838116801(21)117, (01)00884838116801(21)29, (01)00884838116801(21)34, (01)00884838116801(21)10, (01)00884838116801(21)126, (01)00884838116801(21)237, (01)00884838116801(21)125, (01)00884838116801(21)154, (01)00884838116801(21)157, (01)00884838116801(21)30, (01)00884838116801(21)67, (01)00884838116801(21)292, (01)00884838116801(21)289, (01)00884838116801(21)277, (01)00884838116801(21)244, (01)00884838116801(21)181, (01)00884838116801(21)264, (01)00884838116801(21)232, (01)00884838116801(21)207, (01)00884838116801(21)192, (01)00884838116801(21)132, (01)00884838116801(21)128, (01)00884838116801(21)160, (01)00884838116801(21)94, (01)00884838116801(21)86, (01)00884838116801(21)41, (01)00884838116801(21)27, (01)00884838116801(21)259, (01)00884838116801(21)251, (01)00884838116801(21)261, (01)00884838116801(21)57, (01)00884838116801(21)240, (01)00884838116801(21)107, (01)00884838116801(21)172, (01)00884838116801(21)142, (01)00884838116801(21)109, (01)00884838116801(21)55, (01)00884838116801(21)171, (01)00884838116801(21)155, (01)00884838116801(21)175, (01)00884838116801(21)111, (01)00884838116801(21)88, (01)00884838116801(21)104, (01)00884838116801(21)152, (01)00884838116801(21)124, (01)00884838116801(21)103, (01)00884838116801(21)90, (01)00884838116801(21)70, (01)00884838116801(21)153, (01)00884838116801(21)106, (01)00884838116801(21)151, (01)00884838116801(21)144, (01)00884838116801(21)141, (01)00884838116801(21)76, (01)00884838116801(21)112, (01)00884838116801(21)105, (01)00884838116801(21)85, (01)00884838116801(21)62, (01)00884838116801(21)52, (01)00884838116801(21)75, (01)00884838116801(21)92, (01)00884838116801(21)89, (01)00884838116801(21)108, (01)00884838116801(21)59, (01)00884838116801(21)73, (01)00884838116801(21)84, (01)00884838116801(21)69, (01)00884838116801(21)83, (01)00884838116801(21)80, (01)00884838116801(21)64, (01)00884838116801(21)74, (01)00884838116801(21)53, (01)00884838116801(21)49, (01)00884838116801(21)329, (01)00884838116801(21)130, (01)00884838116801(21)326, (01)00884838116801(21)168, (01)00884838116801(21)145, (01)00884838116801(21)146, (01)00884838116801(21)98, (01)00884838116801(21)96, (01)00884838116801(21)93, (01)00884838116801(21)258, (01)00884838116801(21)56, (01)00884838116801(21)91, (01)00884838116801(21)271, (01)00884838116801(21)201, (01)00884838116801(21)123, (01)00884838116801(21)162, (01)00884838116801(21)122, (01)00884838116801(21)114, (01)00884838116801(21)63, (01)00884838116801(21)374, (01)00884838116801(21)357, (01)00884838116801(21)348, (01)00884838116801(21)347, (01)00884838116801(21)352, (01)00884838116801(21)322, (01)00884838116801(21)330, (01)00884838116801(21)321, (01)00884838116801(21)188, (01)00884838116801(21)283, (01)00884838116801(21)285, (01)00884838116801(21)284, (01)00884838116801(21)269, (01)00884838116801(21)193, (01)00884838116801(21)173, (01)00884838116801(21)311, (01)00884838116801(21)156, (01)00884838116801(21)219, (01)00884838116801(21)167, (01)00884838116801(21)33, (01)00884838116801(21)268, (01)00884838116801(21)23, (01)00884838116801(21)361, (01)00884838116801(21)242, (01)00884838116801(21)223, (01)00884838116801(21)234, (01)00884838116801(21)182, (01)00884838116801(21)189, (01)00884838116801(21)165, (01)00884838116801(21)82, (01)00884838116801(21)66, (01)00884838116801(21)13. 7. Model Number: 722233. UDI Numbers: (01)00884838116764(21)118, (01)00884838116764(21)96, (01)00884838116764(21)259, (01)00884838116764(21)169, (01)00884838116764(21)108, (01)00884838116764(21)212, (01)00884838116764(21)267, (01)00884838116764(21)214, (01)00884838116764(21)147, (01)00884838116764(21)153, (01)00884838116764(21)111, (01)00884838116764(21)122, (01)00884838116764(21)124, (01)00884838116764(21)127, (01)00884838116764(21)59, (01)00884838116764(21)172, (01)00884838116764(21)64, (01)00884838116764(21)170, (01)00884838116764(21)41, (01)00884838116764(21)103, (01)00884838116764(21)144, (01)00884838116764(21)219, (01)00884838116764(21)218, (01)00884838116764(21)192, (01)00884838116764(21)30, (01)00884838116764(21)189, (01)00884838116764(21)186, (01)00884838116764(21)17, (01)00884838116764(21)9, (01)00884838116764(21)245, (01)00884838116764(21)57, (01)00884838116764(21)32, (01)00884838116764(21)203, (01)00884838116764(21)205, (01)00884838116764(21)204, (01)00884838116764(21)184, (01)00884838116764(21)162, (01)00884838116764(21)18, (01)00884838116764(2... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1079-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Kosovo, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Palestine, Philippines, Poland, Portugal, R¿union, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jan 21, 2026 - **Recall initiation date**: Dec 8, 2025 - **Center classification date**: Jan 14, 2026 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1079-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. records](https://isitonrecall.com/brand/philips-medical-systems-nederland-b-v/)