Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 6 · Best
Is this the product you have?
8 of 8 products
| Model / number | Product as published |
|---|---|
| — | Azurion 3 M12; Model Numbers: 722063, 722221. |
| — | Azurion 3 M15; Model Numbers: 722064, 722222, 722280. |
722227. | Azurion 5 M12 |
| — | Azurion 5 M20; Model Numbers: 722228, 722281. |
| — | Azurion 7 B12; Model Numbers: 722067, 722225. |
| — | Azurion 7 B20; Model Numbers: 722068, 722226. |
| — | Azurion 7 M12; Model Numbers: 722078, 722223. |
| — | Azurion 7 M20; Model Numbers: 722079, 722224, 722282. Interventional Fluoroscopic X-Ray System. |
- Lot codes and dates
- 1
- Model Numbers (UDI Numbers)
74 of 74 codes
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
- Model Numbers (UDI Numbers)
440 of 440 codes
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
- Model Numbers (UDI Numbers)
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
- Model Numbers (UDI Numbers)
238 of 238 codes
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
- Model Numbers (UDI Numbers)
127 of 127 codes
722067 ((01)00884838085350(21)42(01)00884838085350(21)221(01)00884838085350(21)278(01)00884838085350(21)141(01)00884838085350(21)133(01)00884838085350(21)233(01)00884838085350(21)146(01)00884838085350(21)256(01)00884838085350(21)270(01)00884838085350(21)238(01)00884838085350(21)187(01)00884838085350(21)154(01)00884838085350(21)157(01)00884838085350(21)251(01)00884838085350(21)222(01)00884838085350(21)262(01)00884838085350(21)29(01)00884838085350(21)59(01)00884838085350(21)209(01)00884838085350(21)260(01)00884838085350(21)95(01)00884838085350(21)274(01)00884838085350(21)218(01)00884838085350(21)231(01)00884838085350(21)169(01)00884838085350(21)275(01)00884838085350(21)265(01)00884838085350(21)190(01)00884838085350(21)203(01)00884838085350(21)138(01)00884838085350(21)53(01)00884838085350(21)140(01)00884838085350(21)266(01)00884838085350(21)235(01)00884838085350(21)272(01)00884838085350(21)58(01)00884838085350(21)47(01)00884838085350(21)273(01)00884838085350(21)64(01)00884838085350(21)276(01)00884838085350(21)232(01)00884838085350(21)271(01)00884838085350(21)35(01)00884838085350(21)207(01)00884838085350(21)226(01)00884838085350(21)102(01)00884838085350(21)105(01)00884838085350(21)159(01)00884838085350(21)170(01)00884838085350(21)193(01)00884838085350(21)118(01)00884838085350(21)117(01)00884838085350(21)85(01)00884838085350(21)119)722225 ((01)00884838099265(21)110(01)00884838099265(21)37(01)00884838099265(21)157(01)00884838099265(21)284(01)00884838099265(21)232(01)00884838099265(21)230
- Model Numbers (UDI Numbers)
346 of 346 codes
722068 ((01)00884838085367(21)335(01)00884838085367(21)205(01)00884838085367(21)494(01)00884838085367(21)564(01)00884838085367(21)247(01)00884838085367(21)85(01)00884838085367(21)505(01)00884838085367(21)271(01)00884838085367(21)443(01)00884838085367(21)354(01)00884838085367(21)446(01)00884838085367(21)73(01)00884838085367(21)406(01)00884838085367(21)528(01)00884838085367(21)350(01)00884838085367(21)462(01)00884838085367(21)520(01)00884838085367(21)469(01)00884838085367(21)114(01)00884838085367(21)477(01)00884838085367(21)107(01)00884838085367(21)282(01)00884838085367(21)276(01)00884838085367(21)608(01)00884838085367(21)473(01)00884838085367(21)302(01)00884838085367(21)126(01)00884838085367(21)468(01)00884838085367(21)454(01)00884838085367(21)410(01)00884838085367(21)231(01)00884838085367(21)548(01)00884838085367(21)495(01)00884838085367(21)167(01)00884838085367(21)537(01)00884838085367(21)289(01)00884838085367(21)233(01)00884838085367(21)173(01)00884838085367(21)536(01)00884838085367(21)204(01)00884838085367(21)237(01)00884838085367(21)133(01)00884838085367(21)307(01)00884838085367(21)577(01)00884838085367(21)210(01)00884838085367(21)258(01)00884838085367(21)199(01)00884838085367(21)480(01)00884838085367(21)423(01)00884838085367(21)509(01)00884838085367(21)246(01)00884838085367(21)614(01)00884838085367(21)257(01)00884838085367(21)369(01)00884838085367(21)508(01)00884838085367(21)97(01)00884838085367(21)303(01)00884838085367(21)48(01)00884838085367(21)44(01)00884838085367(21)550
- Model Numbers (UDI Numbers)
440 of 440 codes
722078 ((01)00884838085251(21)585(01)00884838085251(21)613(01)00884838085251(21)224(01)00884838085251(21)479(01)00884838085251(21)278(01)00884838085251(21)921(01)00884838085251(21)165(01)00884838085251(21)657(01)00884838085251(21)576(01)00884838085251(21)645(01)00884838085251(21)379(01)00884838085251(21)166(01)00884838085251(21)258(01)00884838085251(21)257(01)00884838085251(21)143(01)00884838085251(21)661(01)00884838085251(21)520(01)00884838085251(21)535(01)00884838085251(21)170(01)00884838085251(21)298(01)00884838085251(21)725(01)00884838085251(21)728(01)00884838085251(21)906(01)00884838085251(21)603(01)00884838085251(21)719(01)00884838085251(21)163(01)00884838085251(21)271(01)00884838085251(21)412(01)00884838085251(21)748(01)00884838085251(21)309(01)00884838085251(21)635(01)00884838085251(21)232(01)00884838085251(21)612(01)00884838085251(21)986(01)00884838085251(21)135(01)00884838085251(21)589(01)00884838085251(21)738(01)00884838085251(21)343(01)00884838085251(21)344(01)00884838085251(21)943(01)00884838085251(21)898(01)00884838085251(21)482(01)00884838085251(21)693(01)00884838085251(21)694(01)00884838085251(21)265(01)00884838085251(21)511(01)00884838085251(21)746(01)00884838085251(21)266(01)00884838085251(21)178(01)00884838085251(21)179(01)00884838085251(21)526(01)00884838085251(21)264(01)00884838085251(21)287(01)00884838085251(21)1003(01)00884838085251(21)1036(01)00884838085251(21)934(01)00884838085251(21)929(01)00884838085251(21)836(01)00884838085251(21)835(01)00884838085251(21)975
- Model Numbers (UDI Numbers)
1,628 of 1,628 codes
722079 ((01)00884838085268(21)703904(01)00884838085268(21)890(01)00884838085268(21)246(01)00884838085268(21)905(01)00884838085268(21)848(01)00884838085268(21)809(01)00884838085268(21)1032(01)00884838085268(21)820(01)00884838085268(21)1211(01)00884838085268(21)1213(01)00884838085268(21)47(01)00884838085268(21)1365(01)00884838085268(21)856(01)00884838085268(21)703540(01)00884838085268(21)296(01)00884838085268(21)991(01)00884838085268(21)574(01)00884838085268(21)703336(01)00884838085268(21)842(01)00884838085268(21)884(01)00884838085268(21)753(01)00884838085268(21)703493(01)00884838085268(21)407(01)00884838085268(21)877(01)00884838085268(21)703395(01)00884838085268(21)703323(01)00884838085268(21)1108(01)00884838085268(21)1414(01)00884838085268(21)703404(01)00884838085268(21)1355(01)00884838085268(21)703387(01)00884838085268(21)863(01)00884838085268(21)1378(01)00884838085268(21)520(01)00884838085268(21)465(01)00884838085268(21)674(01)00884838085268(21)361(01)00884838085268(21)1021(01)00884838085268(21)608(01)00884838085268(21)611(01)00884838085268(21)895(01)00884838085268(21)883(01)00884838085268(21)525(01)00884838085268(21)885(01)00884838085268(21)843(01)00884838085268(21)703528(01)00884838085268(21)754(01)00884838085268(21)599(01)00884838085268(21)878(01)00884838085268(21)703310(01)00884838085268(21)1285(01)00884838085268(21)703497(01)00884838085268(21)730(01)00884838085268(21)658(01)00884838085268(21)621(01)00884838085268(21)795(01)00884838085268(21)1289(01)00884838085268(21)605(01)00884838085268(21)34(01)00884838085268(21)1222
- Amount recalled
- 3,341 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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