Reported May 27, 2026 · Ongoing
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12…
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 · N/A
Is this the product you have?
- Azurion system
- System Code Description (Model Numbers)
Azurion 3 M12 (722063)Azurion 3 M15 (722064)Azurion 7 B12 (722067)Azurion 7 B20 (722068)Azurion 7 M12 (722078)Azurion 7 M20 (722079722224)
- Lot codes and dates
- 1. Azurion 3 M12
- Model722063
- UDI
71 of 71 codes
(01)00884838085275(21)64(01)00884838085275(21)56(01)00884838085275(21)77(01)00884838085275(21)82(01)00884838085275(21)47(01)00884838085275(21)80(01)00884838085275(21)102(01)00884838085275(21)117(01)00884838085275(21)2(01)00884838085275(21)99(01)00884838085275(21)44(01)00884838085275(21)3(01)00884838085275(21)62(01)00884838085275(21)61(01)00884838085275(21)22(01)00884838085275(21)29(01)00884838085275(21)40(01)00884838085275(21)70(01)00884838085275(21)30(01)00884838085275(21)25(01)00884838085275(21)19(01)00884838085275(21)18(01)00884838085275(21)17(01)00884838085275(21)16(01)00884838085275(21)14(01)00884838085275(21)53(01)00884838085275(21)103(01)00884838085275(21)101(01)00884838085275(21)41(01)00884838085275(21)104(01)00884838085275(21)93(01)00884838085275(21)115(01)00884838085275(21)73(01)00884838085275(21)128(01)00884838085275(21)4(01)00884838085275(21)50(01)00884838085275(21)72(01)00884838085275(21)38(01)00884838085275(21)21(01)00884838085275(21)78(01)00884838085275(21)23(01)00884838085275(21)76(01)00884838085275(21)63(01)00884838085275(21)69(01)00884838085275(21)59(01)00884838085275(21)51(01)00884838085275(21)92(01)00884838085275(21)75(01)00884838085275(21)94(01)00884838085275(21)100(01)00884838085275(21)54(01)00884838085275(21)46(01)00884838085275(21)26(01)00884838085275(21)71(01)00884838085275(21)106(01)00884838085275(21)83(01)00884838085275(21)37(01)00884838085275(21)36(01)00884838085275(21)27(01)00884838085275(21)15
- Model722064
- UDI
145 of 145 codes
(01)00884838085282(21)209(01)00884838085282(21)201(01)00884838085282(21)64(01)00884838085282(21)218(01)00884838085282(21)61(01)00884838085282(21)161(01)00884838085282(21)162(01)00884838085282(21)169(01)00884838085282(21)131(01)00884838085282(21)190(01)00884838085282(21)220(01)00884838085282(21)173(01)00884838085282(21)89(01)00884838085282(21)130(01)00884838085282(21)60(01)00884838085282(21)9(01)00884838085282(21)102(01)00884838085282(21)137(01)00884838085282(21)84(01)00884838085282(21)78(01)00884838085282(21)49(01)00884838085282(21)213(01)00884838085282(21)212(01)00884838085282(21)193(01)00884838085282(21)214(01)00884838085282(21)180(01)00884838085282(21)185(01)00884838085282(21)186(01)00884838085282(21)127(01)00884838085282(21)106(01)00884838085282(21)58(01)00884838085282(21)81(01)00884838085282(21)200(01)00884838085282(21)179(01)00884838085282(21)156(01)00884838085282(21)230(01)00884838085282(21)176(01)00884838085282(21)150(01)00884838085282(21)149(01)00884838085282(21)44(01)00884838085282(21)184(01)00884838085282(21)6(01)00884838085282(21)10(01)00884838085282(21)82(01)00884838085282(21)35(01)00884838085282(21)69(01)00884838085282(21)39(01)00884838085282(21)66(01)00884838085282(21)45(01)00884838085282(21)40(01)00884838085282(21)125(01)00884838085282(21)55(01)00884838085282(21)36(01)00884838085282(21)94(01)00884838085282(21)104(01)00884838085282(21)155(01)00884838085282(21)132(01)00884838085282(21)67(01)00884838085282(21)183(01)00884838085282(21)70
- Model722067
- UDI
139 of 139 codes
(01)00884838085350(21)42(01)00884838085350(21)173(01)00884838085350(21)109(01)00884838085350(21)192(01)00884838085350(21)92(01)00884838085350(21)103(01)00884838085350(21)114(01)00884838085350(21)69(01)00884838085350(21)41(01)00884838085350(21)98(01)00884838085350(21)81(01)00884838085350(21)123(01)00884838085350(21)46(01)00884838085350(21)115(01)00884838085350(21)150(01)00884838085350(21)163(01)00884838085350(21)131(01)00884838085350(21)71(01)00884838085350(21)75(01)00884838085350(21)132(01)00884838085350(21)147(01)00884838085350(21)104(01)00884838085350(21)36(01)00884838085350(21)70(01)00884838085350(21)141(01)00884838085350(21)26(01)00884838085350(21)148(01)00884838085350(21)133(01)00884838085350(21)57(01)00884838085350(21)190(01)00884838085350(21)128(01)00884838085350(21)151(01)00884838085350(21)68(01)00884838085350(21)111(01)00884838085350(21)43(01)00884838085350(21)33(01)00884838085350(21)146(01)00884838085350(21)187(01)00884838085350(21)74(01)00884838085350(21)154(01)00884838085350(21)157(01)00884838085350(21)29(01)00884838085350(21)59(01)00884838085350(21)209(01)00884838085350(21)95(01)00884838085350(21)169(01)00884838085350(21)127(01)00884838085350(21)30(01)00884838085350(21)23(01)00884838085350(21)203(01)00884838085350(21)138(01)00884838085350(21)34(01)00884838085350(21)53(01)00884838085350(21)113(01)00884838085350(21)140(01)00884838085350(21)144(01)00884838085350(21)60(01)00884838085350(21)45(01)00884838085350(21)107(01)00884838085350(21)112
- Model722068
- UDI
270 of 270 codes
(01)00884838085367(21)178(01)00884838085367(21)335(01)00884838085367(21)147(01)00884838085367(21)205(01)00884838085367(21)170(01)00884838085367(21)95(01)00884838085367(21)440(01)00884838085367(21)247(01)00884838085367(21)225(01)00884838085367(21)64(01)00884838085367(21)149(01)00884838085367(21)42(01)00884838085367(21)324(01)00884838085367(21)323(01)00884838085367(21)320(01)00884838085367(21)85(01)00884838085367(21)89(01)00884838085367(21)109(01)00884838085367(21)239(01)00884838085367(21)271(01)00884838085367(21)104(01)00884838085367(21)370(01)00884838085367(21)322(01)00884838085367(21)136(01)00884838085367(21)373(01)00884838085367(21)308(01)00884838085367(21)354(01)00884838085367(21)75(01)00884838085367(21)279(01)00884838085367(21)400(01)00884838085367(21)196(01)00884838085367(21)110(01)00884838085367(21)78(01)00884838085367(21)330(01)00884838085367(21)73(01)00884838085367(21)288(01)00884838085367(21)285(01)00884838085367(21)295(01)00884838085367(21)329(01)00884838085367(21)184(01)00884838085367(21)350(01)00884838085367(21)304(01)00884838085367(21)319(01)00884838085367(21)490(01)00884838085367(21)243(01)00884838085367(21)103(01)00884838085367(21)262(01)00884838085367(21)261(01)00884838085367(21)277(01)00884838085367(21)150(01)00884838085367(21)172(01)00884838085367(21)117(01)00884838085367(21)356(01)00884838085367(21)130(01)00884838085367(21)146(01)00884838085367(21)143(01)00884838085367(21)84(01)00884838085367(21)251(01)00884838085367(21)361(01)00884838085367(21)76
- Model722078
- UDI
500 of 500 codes
(01)00884838085251(21)302(01)00884838085251(21)585(01)00884838085251(21)410(01)00884838085251(21)523(01)00884838085251(21)293(01)00884838085251(21)291(01)00884838085251(21)536(01)00884838085251(21)537(01)00884838085251(21)613(01)00884838085251(21)598(01)00884838085251(21)224(01)00884838085251(21)249(01)00884838085251(21)546(01)00884838085251(21)478(01)00884838085251(21)479(01)00884838085251(21)513(01)00884838085251(21)278(01)00884838085251(21)438(01)00884838085251(21)437(01)00884838085251(21)456(01)00884838085251(21)566(01)00884838085251(21)488(01)00884838085251(21)550(01)00884838085251(21)571(01)00884838085251(21)545(01)00884838085251(21)544(01)00884838085251(21)465(01)00884838085251(21)376(01)00884838085251(21)31(01)00884838085251(21)165(01)00884838085251(21)445(01)00884838085251(21)539(01)00884838085251(21)654(01)00884838085251(21)656(01)00884838085251(21)658(01)00884838085251(21)657(01)00884838085251(21)436(01)00884838085251(21)308(01)00884838085251(21)396(01)00884838085251(21)576(01)00884838085251(21)121(01)00884838085251(21)383(01)00884838085251(21)239(01)00884838085251(21)491(01)00884838085251(21)125(01)00884838085251(21)500(01)00884838085251(21)645(01)00884838085251(21)379(01)00884838085251(21)399(01)00884838085251(21)415(01)00884838085251(21)296(01)00884838085251(21)136(01)00884838085251(21)697(01)00884838085251(21)626(01)00884838085251(21)559(01)00884838085251(21)532(01)00884838085251(21)538(01)00884838085251(21)185(01)00884838085251(21)166(01)00884838085251(21)257
- Model722223
- UDI
(01)00884838099241(21)61(01)00884838099241(21)6(01)00884838099241(21)12(01)00884838099241(21)27. Azurion 7 M20
- Model722079
- UDI
84 of 84 codes
(01)00884838085268(21)1023(01)00884838085268(21)645(01)00884838085268(21)646(01)00884838085268(21)1013(01)00884838085268(21)460(01)00884838085268(21)43(01)00884838085268(21)35(01)00884838085268(21)890(01)00884838085268(21)1137(01)00884838085268(21)1048(01)00884838085268(21)401(01)00884838085268(21)1010(01)00884838085268(21)1054(01)00884838085268(21)536(01)00884838085268(21)534(01)00884838085268(21)535(01)00884838085268(21)266(01)00884838085268(21)818(01)00884838085268(21)412(01)00884838085268(21)617(01)00884838085268(21)246(01)00884838085268(21)488(01)00884838085268(21)53(01)00884838085268(21)57(01)00884838085268(21)905(01)00884838085268(21)55(01)00884838085268(21)992(01)00884838085268(21)691(01)00884838085268(21)809(01)00884838085268(21)848(01)00884838085268(21)1033(01)00884838085268(21)891(01)00884838085268(21)836(01)00884838085268(21)1155(01)00884838085268(21)466(01)00884838085268(21)1157(01)00884838085268(21)263(01)00884838085268(21)420(01)00884838085268(21)673(01)00884838085268(21)298(01)00884838085268(21)297(01)00884838085268(21)299(01)00884838085268(21)564(01)00884838085268(21)838(01)00884838085268(21)1117(01)00884838085268(21)1032(01)00884838085268(21)820(01)00884838085268(21)987(01)00884838085268(21)47(01)00884838085268(21)881(01)00884838085268(21)774(01)00884838085268(21)856(01)00884838085268(21)922(01)00884838085268(21)58(01)00884838085268(21)471(01)00884838085268(21)955(01)00884838085268(21)755(01)00884838085268(21)633(01)00884838085268(21)296(01)00884838085268(21)884
- Amount recalled
- 1651 units (592 US, 1359 OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
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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