Recall archive / FDA device enforcement
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 72223... — FDA record Z-2170-2026
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 Mar 31, 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. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
- Reason
- Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 1,718 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2170-2026
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. System Code Description: Azurion 3 M12. Model Number [UDI]: 722221 [(01)00884838099203(21)181, (01)00884838099203(21)178, (01)00884838099203(21)93]; 722229 [(01)00884838116726(21)22, (01)00884838116726(21)9, (01)00884838116726(21)16, (01)00884838116726(21)15, (01)00884838116726(21)5, (01)00884838116726(21)3, (01)00884838116726(21)4, (01)00884838116726(21)6, (01)00884838116726(21)2, (01)00884838116726(21)8]. 2. System Code Description: Azurion 3 M15. Model Number [UDI]: 722222 [(01)00884838099210(21)358, (01)00884838099210(21)328, (01)00884838099210(21)389, (01)00884838099210(21)378, (01)00884838099210(21)243, (01)00884838099210(21)392, (01)00884838099210(21)396, (01)00884838099210(21)13, (01)00884838099210(21)379, (01)00884838099210(21)385, (01)00884838099210(21)376, (01)00884838099210(21)366, (01)00884838099210(21)365, (01)00884838099210(21)398, (01)00884838099210(21)274]; 722230 [(01)00884838116733(21)40, (01)00884838116733(21)2, (01)00884838116733(21)41, (01)00884838116733(21)15, (01)00884838116733(21)28, (01)00884838116733(21)38, (01)00884838116733(21)9, (01)00884838116733(21)27, (01)00884838116733(21)13]. 3. System Code Description: Azurion 5. Model Number [UDI]: 722281 [(01)00884838110564(21)401, (01)00884838110564(21)427, (01)00884838110564(21)382, (01)00884838110564(21)425]. 4. System Code Description: Azurion 5 M12. Model Number [UDI]: 722227 [(01)00884838099227(21)265, (01)00884838099227(21)360, (01)00884838099227(21)320, (01)00884838099227(21)338, (01)00884838099227(21)324, (01)00884838099227(21)305, (01)00884838099227(21)356, (01)00884838099227(21)346, (01)00884838099227(21)313, (01)00884838099227(21)339, (01)00884838099227(21)321, (01)00884838099227(21)247, (01)00884838099227(21)298, (01)00884838099227(21)337, (01)00884838099227(21)306, (01)00884838099227(21)336, (01)00884838099227(21)318, (01)00884838099227(21)353, (01)00884838099227(21)309, (01)00884838099227(21)310, (01)00884838099227(21)316, (01)00884838099227(21)272, (01)00884838099227(21)345, (01)00884838099227(21)351, (01)00884838099227(21)352, (01)00884838099227(21)258, (01)00884838099227(21)326, (01)00884838099227(21)348, (01)00884838099227(21)355, (01)00884838099227(21)315, (01)00884838099227(21)280, (01)00884838099227(21)300, (01)00884838099227(21)335, (01)00884838099227(21)344, (01)00884838099227(21)308, (01)00884838099227(21)362, (01)00884838099227(21)323, (01)00884838099227(21)331, (01)00884838099227(21)269, (01)00884838099227(21)294, (01)00884838099227(21)342, (01)00884838099227(21)330, (01)00884838099227(21)340, (01)00884838099227(21)284, (01)00884838099227(21)333, (01)00884838099227(21)253, (01)00884838099227(21)301, (01)00884838099227(21)332, (01)00884838099227(21)334, (01)00884838099227(21)297, (01)00884838099227(21)350, (01)00884838099227(21)307, (01)00884838099227(21)311, (01)00884838099227(21)319, (01)00884838099227(21)286, (01)00884838099227(21)329, (01)00884838099227(21)208, (01)00884838099227(21)178]; 722231 [(01)00884838116740(21)52, (01)00884838116740(21)49, (01)00884838116740(21)50, (01)00884838116740(21)41, (01)00884838116740(21)21, (01)00884838116740(21)53, (01)00884838116740(21)47, (01)00884838116740(21)3, (01)00884838116740(21)25, (01)00884838116740(21)34, (01)00884838116740(21)61, (01)00884838116740(21)26, (01)00884838116740(21)7, (01)00884838116740(21)8, (01)00884838116740(21)4, (01)00884838116740(21)5, (01)00884838116740(21)12, (01)00884838116740(21)60, (01)00884838116740(21)28, (01)00884838116740(21)45, (01)00884838116740(21)20, (01)00884838116740(21)19, (01)00884838116740(21)51, (01)00884838116740(21)29, (01)00884838116740(21)27, (01)00884838116740(21)11, (01)00884838116740(21)35, (01)00884838116740(21)62, (01)00884838116740(21)54, (01)00884838116740(21)33, (01)00884838116740(21)1, (01)00884838116740(21)2, (01)00884838116740(21)32]. 5. System Code Description: Azurion 5 M20. Model Number [UDI]: 722228 [(01)00884838099234(21)481, (01)00884838099234(21)537, (01)00884838099234(21)615, (01)00884838099234(21)538, (01)00884838099234(21)533, (01)00884838099234(21)522, (01)00884838099234(21)600, (01)00884838099234(21)642, (01)00884838099234(21)573, (01)00884838099234(21)659, (01)00884838099234(21)567, (01)00884838099234(21)645, (01)00884838099234(21)570, (01)00884838099234(21)560, (01)00884838099234(21)569, (01)00884838099234(21)616, (01)00884838099234(21)568, (01)00884838099234(21)629, (01)00884838099234(21)566, (01)00884838099234(21)571, (01)00884838099234(21)647, (01)00884838099234(21)562, (01)00884838099234(21)640, (01)00884838099234(21)676, (01)00884838099234(21)677, (01)00884838099234(21)602, (01)00884838099234(21)461, (01)00884838099234(21)613, (01)00884838099234(21)393, (01)00884838099234(21)660, (01)00884838099234(21)673, (01)00884838099234(21)580, (01)00884838099234(21)668, (01)00884838099234(21)623, (01)00884838099234(21)486, (01)00884838099234(21)487, (01)00884838099234(21)396, (01)00884838099234(21)172, (01)00884838099234(21)575, (01)00884838099234(21)398, (01)00884838099234(21)392, (01)00884838099234(21)713, (01)00884838099234(21)622, (01)00884838099234(21)588, (01)00884838099234(21)692, (01)00884838099234(21)663, (01)00884838099234(21)705, (01)00884838099234(21)712, (01)00884838099234(21)621, (01)00884838099234(21)710, (01)00884838099234(21)715, (01)00884838099234(21)717, (01)00884838099234(21)706, (01)00884838099234(21)707, (01)00884838099234(21)714, (01)00884838099234(21)718, (01)00884838099234(21)711, (01)00884838099234(21)716, (01)00884838099234(21)708, (01)00884838099234(21)704, (01)00884838099234(21)565, (01)00884838099234(21)703, (01)00884838099234(21)397, (01)00884838099234(21)457, (01)00884838099234(21)458, (01)00884838099234(21)690, (01)00884838099234(21)680, (01)00884838099234(21)657, (01)00884838099234(21)643, (01)00884838099234(21)610, (01)00884838099234(21)646, (01)00884838099234(21)654, (01)00884838099234(21)460, (01)00884838099234(21)601, (01)00884838099234(21)579, (01)00884838099234(21)665, (01)00884838099234(21)628, (01)00884838099234(21)607, (01)00884838099234(21)608, (01)00884838099234(21)650, (01)00884838099234(21)651, (01)00884838099234(21)591, (01)00884838099234(21)595, (01)00884838099234(21)627, (01)00884838099234(21)664, (01)00884838099234(21)356, (01)00884838099234(21)357, (01)00884838099234(21)620, (01)00884838099234(21)545, (01)00884838099234(21)514, (01)00884838099234(21)630, (01)00884838099234(21)626, (01)00884838099234(21)338, (01)00884838099234(21)662, (01)00884838099234(21)689, (01)00884838099234(21)633, (01)00884838099234(21)631, (01)00884838099234(21)581, (01)00884838099234(21)681, (01)00884838099234(21)606, (01)00884838099234(21)519, (01)00884838099234(21)520, (01)00884838099234(21)592, (01)00884838099234(21)614, (01)00884838099234(21)394, (01)00884838099234(21)667, (01)00884838099234(21)532, (01)00884838099234(21)639, (01)00884838099234(21)549, (01)00884838099234(21)368, (01)00884838099234(21)348, (01)00884838099234(21)219, (01)00884838099234(21)634, (01)00884838099234(21)354, (01)00884838099234(21)635, (01)00884838099234(21)597, (01)00884838099234(21)688, (01)00884838099234(21)598, (01)00884838099234(21)637, (01)00884838099234(21)658, (01)00884838099234(21)686, (01)00884838099234(21)611]; 722232 [(01)00884838116757(21)33, (01)00884838116757(21)34, (01)00884838116757(21)49, (01)00884838116757(21)91, (01)00884838116757(21)2, (01)00884838116757(21)96, (01)00884838116757(21)36, (01)00884838116757(21)23, (01)00884838116757(21)108, (01)00884838116757(21)42, (01)00884838116757(21)48, (01)00884838116757(21)46, (01)00884838116757(21)76, (01)00884838116757(21)6, (01)00884838116757(21)60, (01)00884838116757(21)61, (01)00884838116757(21)10, (01)00884838116757(21)43, (01)00884838116757(21)97, (01)00884838116757(21)50, (01)00884838116757(21)75, (01)00884838116757(21)69, (01)00884838116757(21)3, (01)00884838116757(21)67, (01)00884838116757(21)39, (01)00884838116757(21)44, (01)00884838116757(21)37, (01)00884838116757(21)71, (01)00884838116757(21)72, (01)00884838116757(21)93, (01)00884838116757(21)68, (01)00884838116757(21)11, (01)00884838116757(21)77, (01)00884838116757(21)20, (01)00884838116757(21)57, (01)00884838116757(21)58, (01)00884838116757(21)14, (01)00884838116757(21)82, (01)00884838116757(21)115, (01)00884838116757(21)70, (01)00884838116757(21)123, (01)00884838116757(21)81, (01)00884838116757(21)31, (01)00884838116757(21)35, (01)00884838116757(21)28, (01)00884838116757(21)30, (01)00884838116757(21)19, (01)00884838116757(21)102, (01)00884838116757(21)104, (01)00884838116757(21)29, (01)00884838116757(21)56, (01)00884838116757(21)51, (01)00884838116757(21)32, (01)00884838116757(21)105, (01)00884838116757(21)16, (01)00884838116757(21)73, (01)00884838116757(21)100, (01)00884838116757(21)13]; 722281 [(01)00884838110564(21)125, (01)00884838110564(21)176, (01)00884838110564(21)233, (01)00884838110564(21)296, (01)00884838110564(21)74, (01)00884838110564(21)81, (01)00884838110564(21)37, (01)00884838110564(21)135, (01)00884838110564(21)179, (01)00884838110564(21)181, (01)00884838110564(21)182, (01)00884838110564(21)282, (01)00884838110564(21)286, (01)00884838110564(21)109, (01)00884838110564(21)136, (01)00884838110564(21)93, (01)00884838110564(21)153, (01)00884838110564(21)247, (01)00884838110564(21)299, (01)00884838110564(21)140, (01)00884838110564(21)192, (01)00884838110564(21)275, (01)00884838110564(21)127, (01)00884838110564(21)108, (01)00884838110564(21)254, (01)00884838110564(21)255, (01)00884838110564(21)361, (01)00884838110564(21)20, (01)00884838110564(21)328, (01)00884838110564(21)129, (01)00884838110564(21)343, (01)00884838110564(21)215, (01)00884838110564(21)66, (01)00884838110564(21)98, (01)00884838110564(21)235, (01)00884838110564(21)336, (01)00884838110564(21)115, (01)00884838110564(21)120, (01)00884838110564(21)306, (01)00884838110564(21)12, (01)00884838110564(21)65, (01)00884838110564(21)217, (01)00884838110564(21)339, (01)00884838110564(21)351, (01)00884838110564(21)95, (01)00884838110564(21)203, (01)00884838110564(21)236, (01)00884838110564(21)44, (01)00884838110564(21)45, (01)00884838110564(21)319, (01)00884838110564(21)307, (01)00884838110564(21)350, (01)00884838110564(21)164, (01)00884838110564(21)124, (01)00884838110564(21)159, (01)00884838110564(21)71, (01)00884838110564(21)38, (01)00884838110564(21)228, (01)00884838110564(21)272, (01)00884838110564(21)268, (01)00884838110564(21)105, (01)00884838110564(21)260, (01)00884838110564(21)261, (01)00884838110564(21)316, (01)00884838110564(21)265, (01)00884838110564(21)190, (01)00884838110564(21)225, (01)00884838110564(21)186, (01)00884838110564(21)180, (01)00884838110564(21)281, (01)00884838110564(21)202, (01)00884838110564(21)149, (01)00884838110564(21)117, (01)00884838110564(21)52, (01)00884838110564(21)175, (01)00884838110564(21)187, (01)00884838110564(21)219, (01)00884838110564(21)157, (01)00884838110564(21)290, (01)00884838110564(21)102, (01)00884838110564(21)244, (01)00884838110564(21)94, (01)00884838110564(21)110, (01)00884838110564(21)23, (01)00884838110564(21)208, (01)00884838110564(21)209, (01)00884838110564(21)168, (01)00884838110564(21)204, (01)00884838110564(21)114, (01)00884838110564(21)253, (01)00884838110564(21)310, (01)00884838110564(21)155, (01)00884838110564(21)199, (01)00884838110564(21)201, (01)00884838110564(21)161, (01)00884838110564(21)126, (01)00884838110564(21)211, (01)00884838110564(21)287, (01)00884838110564(21)365, (01)00884838110564(21)207, (01)00884838110564(21)85, (01)00884838110564(21)321, (01)00884838110564(21)227, (01)00884838110564(21)276, (01)00884838110564(21)226, (01)00884838110564(21)169, (01)00884838110564(21)156, (01)00884838110564(21)258, (01)00884838110564(21)170, (01)00884838110564(21)407, (01)00884838110564(21)101, (01)00884838110564(21)229, (01)00884838110564(21)146, (01)00884838110564(21)88, (01)00884838110564(21)99, (01)00884838110564(21)188, (01)00884838110564(21)340, (01)00884838110564(21)68, (01)00884838110564(21)151, (01)00884838110564(21)141, (01)00884838110564(21)221, (01)00884838110564(21)41, (01)00884838110564(21)289... |
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
Worldwide distribution - US Nationwide and the country of Canada.
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
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 20, 2026
- Recall initiation date
- Mar 31, 2026
- Center classification date
- May 12, 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.