Lower risk Medical device recall · FDA · Published December 7, 2023

Philips Azurion 3M15: Dark Image Risk with Pedal Tap

Philips recalls Azurion 3M15 models with specific software versions due to dark images appearing after pedal taps during fluoroscopy runs.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2285-2026Medical device Philips ›

Lower-risk recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Take action

Contact the company

Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Veenpluis 6 · Best, Netherlands

✎ GovInfoNow plain-language explainer

Philips is recalling Azurion 3M15 medical imaging devices with certain software versions. These devices may show dark images that aren't clinically usable after a user taps the footswitch pedal without generating an X-ray image. This issue could affect medical procedures requiring accurate imaging. Read more at govinfonow.com/recall/56594-philips-azurion-3m15-dark-image-risk-with-pedal-tap.

Source Summary by GovInfoNow · govinfonow.com/recall/56594-philips-azurion-3m15-dark-image-risk-with-pedal-tap · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2285-2026

Cite this page

“Philips Azurion 3M15: Dark Image Risk with Pedal Tap.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56594-philips-azurion-3m15-dark-image-risk-with-pedal-tap. Based on FDA recall #Z-2285-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2285-2026%22&limit=1).

The FDA announced on Dec. 7, 2023, that Philips Medical Systems Nederland B.V. is recalling Philips Azurion 3M15 imaging systems due to a hazard that may produce dark, clinically unusable images during Roadmap Pro use. Owners should contact Philips for assistance. The recall involves 27 units distributed nationwide.

How to tell if you have it

Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
UPC 00884838085282
UPC 00884838099210

The hazard

According to the FDA, during the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. This hazard may result after the user performs a pedal tap, causing a dark image with the next fluoroscopy run.

Context

GovInfoNow's records show PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 58 other recalls on record since 2021-05-26. On 2026-07-16, Philips recalled Azurion R2.2.10 Systems for potential image quality degradation and loss of geometry movements. Other recent recalls of similar products include Philips Brilliance CT 64 Medical Scanner Recall (2026-08-07) and Philips Ingenuity CT Scanners (2026-08-07).

How to tell if you have this one

Check if your Philips Azurion 3M15 has model numbers 722064 or 722222 and software versions R2.2.0 through R2.2.6. The device may also have unique identifiers listed in the UDI codes provided in the recall notice.

Brand
Philips
Product
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-2284-2026	Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key; UDI (01)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838085275(21)131, (01)00884838099203(21)54, (01)00884838085275(21)84, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838085275(21)132, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)108, (01)00884838085275(21)108.	16 units
Z-2285-2026	Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key; UDI (01)00884838085282(21)209, (01)00884838099210(21)100, (01)00884838099210(21)254, (01)00884838099210(21)256, (01)00884838099210(21)257, (01)00884838099210(21)265, (01)00884838099210(21)255, (01)00884838099210(21)99, (01)00884838085282(21)260, (01)00884838085282(21)261, (01)00884838099210(21)69, (01)00884838099210(21)12, (01)00884838085282(21)314, (01)00884838085282(21)259, (01)00884838099210(21)15, (01)00884838099210(21)19, (01)00884838099210(21)23, (01)00884838099210(21)17, (01)00884838085282(21)258, (01)00884838099210(21)55, (01)00884838099210(21)45, (01)00884838085282(21)270, (01)00884838099210(21)187, (01)00884838099210(21)223, (01)00884838099210(21)44, (01)00884838099210(21)113, (01)00884838099210(21)112.	27 units
Z-2286-2026	Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key; UDI (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63.	3 units
Z-2287-2026	Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key; UDI (01)00884838099234(21)67, (01)00884838099234(21)49, (01)00884838099234(21)10, (01)00884838099234(21)36, (01)00884838099234(21)64, (01)00884838099234(21)110, (01)00884838099234(21)328, (01)00884838099234(21)149, (01)00884838099234(21)213, (01)00884838099234(21)45, (01)00884838099234(21)159, (01)00884838099234(21)18, (01)00884838099234(21)231, (01)00884838099234(21)61, (01)00884838099234(21)204, (01)00884838099234(21)273, (01)00884838099234(21)76, (01)00884838099234(21)150, (01)00884838099234(21)132, (01)00884838099234(21)189, (01)00884838099234(21)17, (01)00884838099234(21)47, (01)00884838099234(21)38, (01)00884838099234(21)87, (01)00884838099234(21)128, (01)00884838099234(21)32, (01)00884838099234(21)23, (01)00884838099234(21)25, (01)00884838099234(21)62, (01)00884838099234(21)181, (01)00884838099234(21)177, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)79, (01)00884838099234(21)80, (01)00884838099234(21)157, (01)00884838099234(21)24, (01)00884838099234(21)187, (01)00884838099234(21)26, (01)00884838099234(21)29, (01)00884838099234(21)122, (01)00884838099234(21)127, (01)00884838099234(21)6, (01)00884838099234(21)123, (01)00884838099234(21)124, (01)00884838099234(21)92, (01)00884838099234(21)215, (01)00884838099234(21)91, (01)00884838099234(21)205, (01)00884838099234(21)20, (01)00884838099234(21)37a.	51 units
Z-2288-2026	Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key; UDI (01)00884838099265(21)104, (01)00884838085350(21)221, (01)00884838099265(21)153, (01)00884838099265(21)46, (01)00884838099265(21)28, (01)00884838085350(21)250, (01)00884838099265(21)72, (01)00884838099265(21)208, (01)00884838099265(21)41, (01)00884838099265(21)122, (01)00884838099265(21)147, (01)00884838085350(21)225, (01)00884838099265(21)262, (01)00884838099265(21)112, (01)00884838099265(21)110, (01)00884838099265(21)207, (01)00884838099265(21)68, (01)00884838099265(21)177, (01)00884838099265(21)29, (01)00884838099265(21)71, (01)00884838099265(21)37, (01)00884838099265(21)175, (01)00884838099265(21)148, (01)00884838099265(21)205, , (01)00884838099265(21)229, (01)00884838099265(21)228, (01)00884838085350(21)277, (01)00884838085350(21)115, (01)00884838099265(21)157, (01)00884838085350(21)163, (01)00884838099265(21)268, (01)00884838085350(21)75, (01)00884838085350(21)132, (01)00884838085350(21)147, (01)00884838085350(21)208, (01)00884838085350(21)104, (01)00884838085350(21)244, (01)00884838085350(21)234, (01)00884838099265(21)53, (01)00884838099265(21)259, (01)00884838099265(21)55, (01)00884838099265(21)235, (01)00884838099265(21)298, (01)00884838085350(21)70, (01)00884838099265(21)233, (01)00884838099265(21)141, (01)00884838099265(21)289, (01)00884838099265(21)249, (01)00884838099265(21)84, (01)00884838099265(21)111, (01)00884838099265(21)227.	51 units
Z-2289-2026	Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key; UDI (01)00884838085367(21)547, (01)00884838099272(21)120, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099272(21)124, (01)00884838099272(21)125, (01)00884838099272(21)126, (01)00884838099272(21)127, (01)00884838099272(21)153, (01)00884838099272(21)67, (01)00884838099272(21)209, (01)00884838099272(21)271, (01)00884838099272(21)675, (01)00884838099272(21)112, (01)00884838085367(21)467, (01)00884838085367(21)335, (01)00884838099272(21)113, (01)00884838099272(21)121, (01)00884838099272(21)139, (01)00884838099272(21)158, (01)00884838085367(21)455, (01)00884838085367(21)494, (01)00884838099272(21)239, (01)00884838099272(21)105, (01)00884838099272(21)678, (01)00884838099272(21)362, (01)00884838099272(21)114, (01)00884838085367(21)564, (01)00884838099272(21)403, (01)00884838085367(21)418, (01)00884838085367(21)440, (01)00884838099272(21)108, (01)00884838099272(21)545, (01)00884838099272(21)197, (01)00884838099272(21)380, (01)00884838099272(21)281, (01)00884838099272(21)495, (01)00884838099272(21)319, (01)00884838099272(21)339, (01)00884838099272(21)182, (01)00884838099272(21)183, (01)00884838085367(21)64, (01)00884838099272(21)325, (01)00884838099272(21)100, (01)00884838099272(21)272, (01)00884838099272(21)680, (01)00884838085367(21)42, (01)00884838099272(21)255, (01)00884838099272(21)341, (01)00884838099272(21)687, (01)00884838099272(21)350, (01)00884838099272(21)280, (01)00884838085367(21)323, (01)00884838099272(21)270, (01)00884838099272(21)254, (01)00884838099272(21)107, (01)00884838099272(21)144, (01)00884838085367(21)109, (01)00884838099272(21)294, (01)00884838099272(21)559, (01)00884838099272(21)98, (01)00884838099272(21)343, (01)00884838085367(21)443, (01)00884838099272(21)301, (01)00884838099272(21)117, (01)00884838085367(21)322, (01)00884838085367(21)373, (01)00884838085367(21)442, (01)00884838099272(21)244, (01)00884838099272(21)332, (01)00884838085367(21)308, (01)00884838099272(21)78, (01)00884838099272(21)374, (01)00884838099272(21)11, (01)00884838085367(21)354, (01)00884838099272(21)441, (01)00884838099272(21)129, (01)00884838099272(21)180, (01)00884838085367(21)279, (01)00884838099272(21)442, (01)00884838085367(21)400, (01)00884838099272(21)220, (01)00884838099272(21)189, (01)00884838099272(21)190, (01)00884838099272(21)446, (01)00884838085367(21)510, (01)00884838085367(21)111, (01)00884838085367(21)113, (01)00884838085367(21)446, (01)00884838099272(21)208, (01)00884838099272(21)554, (01)00884838085367(21)330, (01)00884838085367(21)288, (01)00884838099272(21)360, (01)00884838099272(21)337, (01)00884838099272(21)159, (01)00884838099272(21)326, (01)00884838099272(21)400, (01)00884838085367(21)329, (01)00884838099272(21)175, (01)00884838099272(21)427, (01)00884838099272(21)464, (01)00884838099272(21)468, (01)00884838085367(21)472, (01)00884838085367(21)470, (01)00884838085367(21)457, (01)00884838085367(21)520, (01)00884838085367(21)490, (01)00884838099272(21)143, (01)00884838099272(21)262, (01)00884838085367(21)103, (01)00884838099272(21)391, (01)00884838085367(21)150, (01)00884838085367(21)277, (01)00884838099272(21)173, (01)00884838085367(21)172, (01)00884838099272(21)147, (01)00884838099272(21)204, (01)00884838099272(21)467, (01)00884838085367(21)356, (01)00884838085367(21)130, (01)00884838099272(21)260, (01)00884838099272(21)381, (01)00884838099272(21)508, (01)00884838099272(21)419, (01)00884838099272(21)313, (01)00884838085367(21)469, (01)00884838099272(21)472, (01)00884838099272(21)318, (01)00884838099272(21)473, (01)00884838085367(21)431, (01)00884838099272(21)174, (01)00884838099272(21)383, (01)00884838099272(21)181, (01)00884838099272(21)463, (01)00884838099272(21)205, (01)00884838099272(21)59, (01)00884838099272(21)361, (01)00884838085367(21)114, (01)00884838099272(21)555, (01)00884838099272(21)379, (01)00884838085367(21)511, (01)00884838085367(21)477, (01)00884838099272(21)266, (01)00884838099272(21)398, (01)00884838099272(21)593, (01)00884838099272(21)75, (01)00884838099272(21)19, (01)00884838085367(21)413, (01)00884838085367(21)337, (01)00884838099272(21)215, (01)00884838099272(21)213, (01)00884838099272(21)214, (01)00884838099272(21)469, (01)00884838099272(21)219, (01)00884838099272(21)462.	156 units
Z-2290-2026	Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key; UDI (01)00884838099241(21)85, (01)00884838099241(21)312, (01)00884838099241(21)332, (01)00884838099241(21)533, (01)00884838099241(21)479, (01)00884838099241(21)189, (01)00884838099241(21)47, (01)00884838085251(21)840, (01)00884838099241(21)352, (01)00884838099241(21)681, (01)00884838099241(21)391, (01)00884838099241(21)328, (01)00884838085251(21)870, (01)00884838099241(21)388, (01)00884838099241(21)581, (01)00884838099241(21)570, (01)00884838099241(21)77, (01)00884838099241(21)448, (01)00884838099241(21)571, (01)00884838099241(21)495, (01)00884838085251(21)679, (01)00884838099241(21)439, (01)00884838099241(21)628, (01)00884838099241(21)36, (01)00884838099241(21)580, (01)00884838099241(21)799, (01)00884838099241(21)577, (01)00884838085251(21)513, (01)00884838085251(21)833, (01)00884838085251(21)566, (01)00884838099241(21)323, (01)00884838099241(21)252, (01)00884838099241(21)626, (01)00884838099241(21)261, (01)00884838099241(21)125, (01)00884838099241(21)207, (01)00884838099241(21)329, (01)00884838099241(21)560, (01)00884838099241(21)561, (01)00884838099241(21)205, (01)00884838099241(21)379, (01)00884838099241(21)440, (01)00884838099241(21)204, (01)00884838099241(21)192, (01)00884838099241(21)197, (01)00884838085251(21)921, (01)00884838099241(21)177, (01)00884838085251(21)700, (01)00884838099241(21)37, (01)00884838099241(21)340, (01)00884838099241(21)357, (01)00884838099241(21)282, (01)00884838099241(21)214, (01)00884838085251(21)1007, (01)00884838099241(21)44, (01)00884838085251(21)862, (01)00884838099241(21)210, (01)00884838099241(21)336, (01)00884838099241(21)206, (01)00884838099241(21)343, (01)00884838085251(21)786, (01)00884838099241(21)365, (01)00884838099241(21)390, (01)00884838099241(21)186, (01)00884838099241(21)187, (01)00884838099241(21)631, (01)00884838099241(21)87, (01)00884838099241(21)373, (01)00884838099241(21)514, (01)00884838099241(21)69, (01)00884838099241(21)256, (01)00884838099241(21)679, (01)00884838099241(21)29, (01)00884838099241(21)67, (01)00884838099241(21)503, (01)00884838099241(21)432, (01)00884838099241(21)131, (01)00884838099241(21)704, (01)00884838099241(21)301, (01)00884838099241(21)456, (01)00884838085251(21)803, (01)00884838099241(21)659, (01)00884838099241(21)242, (01)00884838099241(21)746, (01)00884838099241(21)171, (01)00884838099241(21)457, (01)00884838099241(21)455, (01)00884838099241(21)221, (01)00884838099241(21)454, (01)00884838099241(21)318, (01)00884838099241(21)229, (01)00884838099241(21)230, (01)00884838099241(21)262, (01)00884838085251(21)890, (01)00884838085251(21)626, (01)00884838085251(21)697, (01)00884838099241(21)308, (01)00884838099241(21)124, (01)00884838099241(21)198, (01)00884838099241(21)433, (01)00884838085251(21)684, (01)00884838099241(21)566, (01)00884838099241(21)126, (01)00884838085251(21)829, (01)00884838099241(21)880, (01)00884838085251(21)143, (01)00884838099241(21)665, (01)00884838099241(21)188, (01)00884838085251(21)824, (01)00884838085251(21)649, (01)00884838099241(21)367, (01)00884838099241(21)52, (01)00884838099241(21)371, (01)00884838099241(21)127, (01)00884838099241(21)105, (01)00884838099241(21)572, (01)00884838099241(21)104, (01)00884838099241(21)334, (01)00884838099241(21)627, (01)00884838099241(21)458, (01)00884838099241(21)487, (01)00884838099241(21)463, (01)00884838099241(21)470, (01)00884838085251(21)902, (01)00884838099241(21)96, (01)00884838099241(21)277, (01)00884838099241(21)211, (01)00884838085251(21)317, (01)00884838085251(21)709, (01)00884838099241(21)97, (01)00884838099241(21)161, (01)00884838099241(21)386, (01)00884838099241(21)208, (01)00884838099241(21)361, (01)00884838099241(21)258, (01)00884838099241(21)597, (01)00884838085251(21)725, (01)00884838085251(21)728, (01)00884838099241(21)180, (01)00884838085251(21)441, (01)00884838099241(21)668, (01)00884838099241(21)377, (01)00884838099241(21)882, (01)00884838085251(21)906, (01)00884838099241(21)565, (01)00884838099241(21)223, (01)00884838099241(21)196, (01)00884838099241(21)130, (01)00884838099241(21)453, (01)00884838099241(21)452, (01)00884838099241(21)269, (01)00884838085251(21)788, (01)00884838099241(21)567, (01)00884838099241(21)449, (01)00884838085251(21)141, (01)00884838085251(21)279, (01)00884838085251(21)644, (01)00884838099241(21)435, (01)00884838099241(21)441, (01)00884838085251(21)844, (01)00884838085251(21)876, (01)00884838085251(21)748, (01)00884838099241(21)669, (01)00884838099241(21)351, (01)00884838099241(21)508, (01)00884838099241(21)750, (01)00884838099241(21)164.	167 units
Z-2291-2026	Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key; UDI (01)00884838099258(21)450, (01)00884838099258(21)750, (01)00884838099258(21)409, (01)00884838099258(21)262, (01)00884838099258(21)275, (01)00884838099258(21)277, (01)00884838099258(21)295, (01)00884838099258(21)272, (01)00884838099258(21)261, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838099258(21)1315, (01)00884838099258(21)381, (01)00884838099258(21)959, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838085268(21)460, (01)00884838085268(21)1387, (01)00884838099258(21)260, (01)00884838099258(21)1019, (01)00884838099258(21)1371, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838085268(21)35, (01)00884838099258(21)1049, (01)00884838099258(21)1484, (01)00884838099258(21)1083, (01)00884838085268(21)703307, (01)00884838099258(21)246, (01)00884838099258(21)475.	31 units

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify your Philips Azurion 3M15 model number (722064 or 722222) and software version (R2.2.0 to R2.2.6).
Contact Philips Support
Reach out to Philips customer support for guidance on whether your device is affected and next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2.5 years after the firm started it.

Dec 7, 2023Firm started the recall
Jun 1, 2026FDA classified it Class II
Jun 10, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/56594-philips-azurion-3m15-dark-image-risk-with-pedal-tap">Philips Azurion 3M15: Dark Image Risk with Pedal Tap (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2285-2026 (December 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2285-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.