Recall archive / FDA device enforcement
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions... — FDA record Z-2225-2026
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 Apr 28, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 5,537 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2225-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1. Model Number [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, (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. Model Number [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, (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, (01)00884838085282(21)125, (01)00884838085282(21)484, (01)00884838085282(21)36, (01)00884838085282(21)94, (01)00884838085282(21)422, (01)00884838085282(21)132, (01)00884838085282(21)183, (01)00884838085282(21)439, (01)00884838085282(21)446, (01)00884838085282(21)293, (01)00884838085282(21)379, (01)00884838085282(21)292, (01)00884838085282(21)321, (01)00884838085282(21)151, (01)00884838085282(21)237, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)208, (01)00884838085282(21)462, (01)00884838085282(21)342, (01)00884838085282(21)391, (01)00884838085282(21)441, (01)00884838085282(21)320, (01)00884838085282(21)494, (01)00884838085282(21)79, (01)00884838085282(21)311, (01)00884838085282(21)442, (01)00884838085282(21)485, (01)00884838085282(21)252, (01)00884838085282(21)91, (01)00884838085282(21)73, (01)00884838085282(21)74, (01)00884838085282(21)309, (01)00884838085282(21)400, (01)00884838085282(21)251, (01)00884838085282(21)480, (01)00884838085282(21)387, (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, (01)00884838085282(21)514, (01)00884838085282(21)333, (01)00884838085282(21)236, (01)00884838085282(21)471, (01)00884838085282(21)401, (01)00884838085282(21)234, (01)00884838085282(21)503, (01)00884838085282(21)394, (01)00884838085282(21)407, (01)00884838085282(21)470, (01)00884838085282(21)498, (01)00884838085282(21)413, (01)00884838085282(21)440, (01)00884838085282(21)463, (01)00884838085282(21)330, (01)00884838085282(21)475, (01)00884838085282(21)473, (01)00884838085282(21)501, (01)00884838085282(21)308, (01)00884838085282(21)225, (01)00884838085282(21)483, (01)00884838085282(21)474, (01)00884838085282(21)344, (01)00884838085282(21)389, (01)00884838085282(21)492, (01)00884838085282(21)324, (01)00884838085282(21)265, (01)00884838085282(21)235, (01)00884838085282(21)120, (01)00884838085282(21)496, (01)00884838085282(21)427, (01)00884838085282(21)51, (01)00884838085282(21)388, (01)00884838085282(21)177, (01)00884838085282(21)47, (01)00884838085282(21)59, (01)00884838085282(21)167, (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, (01)00884838085282(21)327, (01)00884838085282(21)144, (01)00884838085282(21)227, (01)00884838085282(21)295, (01)00884838085282(21)294, (01)00884838085282(21)319, (01)00884838085282(21)241, (01)00884838085282(21)126, (01)00884838085282(21)92, (01)00884838085282(21)284, (01)00884838085282(21)175, (01)00884838085282(21)199, (01)00884838085282(21)372, (01)00884838085282(21)188, (01)00884838085282(21)429, (01)00884838085282(21)296, (01)00884838085282(21)172, (01)00884838085282(21)283, (01)00884838085282(21)357, (01)00884838085282(21)306, (01)00884838085282(21)437, (01)00884838085282(21)210, (01)00884838085282(21)315, (01)00884838085282(21)134, (01)00884838085282(21)255, (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)313, (01)00884838085282(21)187, (01)00884838085282(21)166, (01)00884838085282(21)96, (01)00884838085282(21)135]; 722222 [(01)00884838099210(21)101, (01)00884838099210(21)318, (01)00884838099210(21)364, (01)00884838099210(21)146, (01)00884838099210(21)269, (01)00884838099210(21)75, (01)00884838099210(21)246, (01)00884838099210(21)304, (01)00884838099210(21)316, (01)00884838099210(21)338, (01)00884838099210(21)345, (01)00884838099210(21)344, (01)00884838099210(21)343, (01)00884838099210(21)336, (01)00884838099210(21)339, (01)00884838099210(21)346, (01)00884838099210(21)340, (01)00884838099210(21)27, (01)00884838099210(21)312, (01)00884838099210(21)172, (01)00884838099210(21)35, (01)00884838099210(21)151, (01)00884838099210(21)277, (01)00884838099210(21)224, (01)00884838099210(21)102, (01)00884838099210(21)88, (01)00884838099210(21)145, (01)00884838099210(21)89, (01)00884838099210(21)108, (01)00884838099210(21)132, (01)00884838099210(21)48, (01)00884838099210(21)305, (01)00884838099210(21)80, (01)00884838099210(21)83, (01)00884838099210(21)47, (01)00884838099210(21)270, (01)00884838099210(21)21, (01)00884838099210(21)64, (01)00884838099210(21)22, (01)00884838099210(21)22A, (01)00884838099210(21)98, (01)00884838099210(21)29, (01)00884838099210(21)248, (01)00884838099210(21)369, (01)00884838099210(21)389, (01)00884838099210(21)222, (01)00884838099210(21)134, (01)00884838099210(21)266, (01)00884838099210(21)378, (01)00884838099210(21)245, (01)00884838099210(21)24, (01)00884838099210(21)244, (01)00884838099210(21)335, (01)00884838099210(21)177, (01)00884838099210(21)11, (01)00884838099210(21)72, (01)00884838099210(21)50, (01)00884838099210(21)263, (01)00884838099210(21)65, (01)00884838099210(21)278, (01)00884838099210(21)188, (01)00884838099210(21)68, (01)00884838099210(21)51, (01)00884838099210(21)76, (01)00884838099210(21)243, (01)00884838099210(21)31, (01)00884838099210(21)193, (01)00884838099210(21)106, (01)00884838099210(21)268, (01)00884838099210(21)104, (01)00884838099210(21)105, (01)00884838099210(21)252, (01)00884838099210(21)250, 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(01)00884838099210(21)38, (01)00884838099210(21)10, (01)00884838099210(21)67, (01)0088483809... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
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- West Virginia
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Dates in the source
- Report date
- May 27, 2026
- Recall initiation date
- Apr 28, 2026
- Center classification date
- May 21, 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.