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RecallWatchMedical Device Safety
Class IIOngoingZ-2892-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion under the following System Descriptions and corresponding model numbers…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported Aug 12, 2026 · 6 days ago
Legal News Analyst ·

Reason for recall

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

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 under the following System Descriptions and corresponding model numbers: 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. Interventional Fluoroscopic X-Ray System.

Lot / code information

UDI
): 722063 ((01)00884838085275(21)56, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)3 — +68 moreShow all
): 722063 ((01)00884838085275(21)56, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)3, (01)00884838085275(21)22, (01)00884838085275(21)153, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)19, (01)00884838085275(21)121, (01)00884838085275(21)18, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)151, (01)00884838085275(21)137, (01)00884838085275(21)73, (01)00884838085275(21)150, (01)00884838085275(21)105, (01)00884838085275(21)129, (01)00884838085275(21)59, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)89, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)140, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55), 722221 ((01)00884838099203(21)93, (01)00884838099203(21)108, (01)00884838099203(21)101, (01)00884838099203(21)124, (01)00884838099203(21)4, (01)00884838099203(21)106, (01)00884838099203(21)151, (01)00884838099203(21)71, (01)00884838099203(21)105, (01)00884838099203(21)60, (01)00884838099203(21)33, (01)00884838099203(21)55, (01)00884838099203(21)44, (01)00884838099203(21)74, (01)00884838099203(21)142, (01)00884838099203(21)144, (01)00884838099203(21)147, (01)00884838099203(21)96, (01)00884838099203(21)92, (01)00884838099203(21)78, (01)00884838099203(21)23, (01)00884838099203(21)133, (01)00884838099203(21)167, (01)00884838099203(21)26, (01)00884838099203(21)15, (01)00884838099203(21)163, (01)00884838099203(21)67, (01)00884838099203(21)81, (01)00884838099203(21)22). 2
UDI
): 722064 ((01)00884838085282(21)258, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)64, (01)00884838085282(21)218 — +434 moreShow all
): 722064 ((01)00884838085282(21)258, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)513, (01)00884838085282(21)297, (01)00884838085282(21)169, (01)00884838085282(21)479, (01)00884838085282(21)359, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)502, (01)00884838085282(21)157, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)263, (01)00884838085282(21)264, (01)00884838085282(21)253, (01)00884838085282(21)254, (01)00884838085282(21)280, (01)00884838085282(21)102, (01)00884838085282(21)461, (01)00884838085282(21)510, (01)00884838085282(21)345, (01)00884838085282(21)185, (01)00884838085282(21)193, (01)00884838085282(21)271, (01)00884838085282(21)214, (01)00884838085282(21)212, (01)00884838085282(21)266, (01)00884838085282(21)213, (01)00884838085282(21)180, (01)00884838085282(21)431, (01)00884838085282(21)354, (01)00884838085282(21)374, (01)00884838085282(21)106, (01)00884838085282(21)58, (01)00884838085282(21)288, (01)00884838085282(21)231, (01)00884838085282(21)287, (01)00884838085282(21)150, (01)00884838085282(21)380, (01)00884838085282(21)233, (01)00884838085282(21)230, (01)00884838085282(21)44, (01)00884838085282(21)197, (01)00884838085282(21)176, (01)00884838085282(21)149, (01)00884838085282(21)289, (01)00884838085282(21)448, (01)00884838085282(21)82, (01)00884838085282(21)323, (01)00884838085282(21)35, (01)00884838085282(21)55, (01)00884838085282(21)45, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)484, (01)00884838085282(21)36, (01)00884838085282(21)104, (01)00884838085282(21)155, (01)00884838085282(21)422, (01)00884838085282(21)132, (01)00884838085282(21)67, (01)00884838085282(21)439, (01)00884838085282(21)446, (01)00884838085282(21)138, (01)00884838085282(21)293, (01)00884838085282(21)292, (01)00884838085282(21)379, (01)00884838085282(21)321, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)208, (01)00884838085282(21)462, (01)00884838085282(21)342, (01)00884838085282(21)222, (01)00884838085282(21)391, (01)00884838085282(21)98, (01)00884838085282(21)441, (01)00884838085282(21)320, (01)00884838085282(21)494, (01)00884838085282(21)87, (01)00884838085282(21)109, (01)00884838085282(21)311, (01)00884838085282(21)442, (01)00884838085282(21)485, (01)00884838085282(21)121, (01)00884838085282(21)68, (01)00884838085282(21)384, (01)00884838085282(21)228, (01)00884838085282(21)91, (01)00884838085282(21)252, (01)00884838085282(21)73, (01)00884838085282(21)74, (01)00884838085282(21)124, (01)00884838085282(21)191, (01)00884838085282(21)122, (01)00884838085282(21)421, (01)00884838085282(21)400, (01)00884838085282(21)480, (01)00884838085282(21)387, (01)00884838085282(21)11, (01)00884838085282(21)48, (01)00884838085282(21)147, (01)00884838085282(21)509, (01)00884838085282(21)454, (01)00884838085282(21)478, (01)00884838085282(21)262, (01)00884838085282(21)491, (01)00884838085282(21)133, (01)00884838085282(21)337, (01)00884838085282(21)275, (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)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)444, (01)00884838085282(21)508, (01)00884838085282(21)445, (01)00884838085282(21)395, (01)00884838085282(21)385, (01)00884838085282(21)514, (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)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)496, (01)00884838085282(21)427, (01)00884838085282(21)341, (01)00884838085282(21)118, (01)00884838085282(21)174, (01)00884838085282(21)452, (01)00884838085282(21)168, (01)00884838085282(21)447, (01)00884838085282(21)198, (01)00884838085282(21)312, (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)43, (01)00884838085282(21)488, (01)00884838085282(21)416, (01)00884838085282(21)12, (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)215, (01)00884838085282(21)144, (01)00884838085282(21)227, (01)00884838085282(21)295, (01)00884838085282(21)294, (01)00884838085282(21)319, (01)00884838085282(21)126, (01)00884838085282(21)92, (01)00884838085282(21)175, (01)00884838085282(21)372, (01)00884838085282(21)429, (01)00884838085282(21)283, (01)00884838085282(21)357, (01)00884838085282(21)437, (01)00884838085282(21)315, (01)00884838085282(21)134, (01)00884838085282(21)255, (01)00884838085282(21)192, (01)00884838085282(21)116, (01)00884838085282(21)221, (01)00884838085282(21)117, (01)00884838085282(21)96, (01)00884838085282(21)135, (01)00884838085282(21)72), 722222 ((01)00884838099210(21)254, (01)00884838099210(21)226, (01)00884838099210(21)55, (01)00884838099210(21)44, (01)00884838099210(21)262, (01)00884838 …
UDI
): 722227 ((01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)127, (01)00884838099227(21)128, (01)00884838099227(21)179, (01)00884838099227(21)246 — +42 moreShow all
): 722227 ((01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)127, (01)00884838099227(21)128, (01)00884838099227(21)179, (01)00884838099227(21)246, (01)00884838099227(21)84, (01)00884838099227(21)29, (01)00884838099227(21)108, (01)00884838099227(21)62, (01)00884838099227(21)25, (01)00884838099227(21)104, (01)00884838099227(21)109, (01)00884838099227(21)249, (01)00884838099227(21)215, (01)00884838099227(21)167, (01)00884838099227(21)83, (01)00884838099227(21)195, (01)00884838099227(21)116, (01)00884838099227(21)153, (01)00884838099227(21)262, (01)00884838099227(21)113, (01)00884838099227(21)110, (01)00884838099227(21)219, (01)00884838099227(21)256, (01)00884838099227(21)90, (01)00884838099227(21)69, (01)00884838099227(21)200, (01)00884838099227(21)242, (01)00884838099227(21)136, (01)00884838099227(21)137, (01)00884838099227(21)294, (01)00884838099227(21)95, (01)00884838099227(21)165, (01)00884838099227(21)16, (01)00884838099227(21)12, (01)00884838099227(21)257, (01)00884838099227(21)248, (01)00884838099227(21)106, (01)00884838099227(21)26, (01)00884838099227(21)44, (01)00884838099227(21)130, (01)00884838099227(21)58, (01)00884838099227(21)125, (01)00884838099227(21)184, (01)00884838099227(21)57, (01)00884838099227(21)259, (01)00884838099227(21)131). 4
UDI
): 722228 ((01)00884838099234(21)49, (01)00884838099234(21)159, (01)00884838099234(21)273, (01)00884838099234(21)132, (01)00884838099234(21)47, (01)00884838099234(21)87 — +232 moreShow all
): 722228 ((01)00884838099234(21)49, (01)00884838099234(21)159, (01)00884838099234(21)273, (01)00884838099234(21)132, (01)00884838099234(21)47, (01)00884838099234(21)87, (01)00884838099234(21)38, (01)00884838099234(21)32, (01)00884838099234(21)25, (01)00884838099234(21)23, (01)00884838099234(21)62, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)431, (01)00884838099234(21)113, (01)00884838099234(21)127, (01)00884838099234(21)91, (01)00884838099234(21)529, (01)00884838099234(21)145, (01)00884838099234(21)539, (01)00884838099234(21)308, (01)00884838099234(21)335, (01)00884838099234(21)333, (01)00884838099234(21)44, (01)00884838099234(21)418, (01)00884838099234(21)525, (01)00884838099234(21)280, (01)00884838099234(21)387, (01)00884838099234(21)471, (01)00884838099234(21)428, (01)00884838099234(21)465, (01)00884838099234(21)103, (01)00884838099234(21)176, (01)00884838099234(21)102, (01)00884838099234(21)178, (01)00884838099234(21)109, (01)00884838099234(21)16, (01)00884838099234(21)234, (01)00884838099234(21)463, (01)00884838099234(21)71, (01)00884838099234(21)317, (01)00884838099234(21)517, (01)00884838099234(21)203, (01)00884838099234(21)260, (01)00884838099234(21)107, (01)00884838099234(21)101, (01)00884838099234(21)99, (01)00884838099234(21)100, (01)00884838099234(21)108, (01)00884838099234(21)318, (01)00884838099234(21)75, (01)00884838099234(21)78, (01)00884838099234(21)531, (01)00884838099234(21)370, (01)00884838099234(21)464, (01)00884838099234(21)138, (01)00884838099234(21)496, (01)00884838099234(21)312, (01)00884838099234(21)223, (01)00884838099234(21)218, (01)00884838099234(21)513, (01)00884838099234(21)442, (01)00884838099234(21)174, (01)00884838099234(21)548, (01)00884838099234(21)84, (01)00884838099234(21)454, (01)00884838099234(21)346, (01)00884838099234(21)327, (01)00884838099234(21)196, (01)00884838099234(21)415, (01)00884838099234(21)118, (01)00884838099234(21)452, (01)00884838099234(21)179, (01)00884838099234(21)331, 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Additional code information

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What the firm is doing

Philips notified consignees on about 06/17/2026 via letter sent certified mail titled, URGENT Medical Device Correction. Consignees were instructed to circulate the notification letter to all users of the system for awareness and to follow the instructions. In the case motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2) and rotational (3) stand movements remain available. Note: Transversal stand movements (2) are only available for ceiling-mounted systems with the FlexMove option. For floor-mounted systems, only rotational (3) stand movements remain available. The table longitudinal position (4) can be adjusted manually, when the table is not tilted. Additionally, consignees were instructed to provide a copy of the notification letter to any organizations to which affected units have been transferred to, to keep the notification letter with system documentation until the correction is complete and complete and return the provided response form. Philips will inspect all affected systems and replace HDDs that are not according to the specifications, as well as correct configurations where different HDD types are used within a single system. Philips expects to start the implementation of this correction in September 2026.

DistributionShow details

US Nationwide distribution.

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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