Reported Jan 21, 2026 · Ongoing
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models
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 4-6 · Best · N/A
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Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models
8 of 8 products
| Model / number | Product as published |
|---|---|
722229. | Azurion 3 M12. |
722230. | Azurion 3 M15. |
722231. | Azurion 5 M12. |
722232. | Azurion 5 M20. |
722235. | Azurion 7 B12. |
722236. | Azurion 7 B20. |
722233. | Azurion 7 M12. |
722234. | Azurion 7 M20. |
- Lot codes and dates
- Software VersionR3.0. 1
- Model Number722229
- UDI Numbers
(01)00884838116726(21)22(01)00884838116726(21)15(01)00884838116726(21)16(01)00884838116726(21)6(01)00884838116726(21)8(01)00884838116726(21)4(01)00884838116726(21)24(01)00884838116726(21)26(01)00884838116726(21)20(01)00884838116726(21)25(01)00884838116726(21)11(01)00884838116726(21)21(01)00884838116726(21)13(01)00884838116726(21)7(01)00884838116726(21)10(01)00884838116726(21)2(01)00884838116726(21)3(01)00884838116726(21)29. 2
- Model Number722230
- UDI Numbers
(01)00884838116733(21)2(01)00884838116733(21)40(01)00884838116733(21)9(01)00884838116733(21)1(01)00884838116733(21)38(01)00884838116733(21)10(01)00884838116733(21)45(01)00884838116733(21)7(01)00884838116733(21)27(01)00884838116733(21)28(01)00884838116733(21)39(01)00884838116733(21)4(01)00884838116733(21)5(01)00884838116733(21)23(01)00884838116733(21)41(01)00884838116733(21)20(01)00884838116733(21)19(01)00884838116733(21)13(01)00884838116733(21)15(01)00884838116733(21)12(01)00884838116733(21)22. 3
- Model Number722231
- UDI Numbers
(01)00884838116740(21)13(01)00884838116740(21)29(01)00884838116740(21)50(01)00884838116740(21)21(01)00884838116740(21)19(01)00884838116740(21)12(01)00884838116740(21)25(01)00884838116740(21)4(01)00884838116740(21)1(01)00884838116740(21)5(01)00884838116740(21)2(01)00884838116740(21)73(01)00884838116740(21)72(01)00884838116740(21)75(01)00884838116740(21)33(01)00884838116740(21)47(01)00884838116740(21)60(01)00884838116740(21)53(01)00884838116740(21)45(01)00884838116740(21)61(01)00884838116740(21)34(01)00884838116740(21)54(01)00884838116740(21)35(01)00884838116740(21)49(01)00884838116740(21)32(01)00884838116740(21)28(01)00884838116740(21)27(01)00884838116740(21)26(01)00884838116740(21)51(01)00884838116740(21)11(01)00884838116740(21)20(01)00884838116740(21)41(01)00884838116740(21)52(01)00884838116740(21)3. 4
- Model Number722232
- UDI Numbers
(01)00884838116757(21)61(01)00884838116757(21)60(01)00884838116757(21)5(01)00884838116757(21)49(01)00884838116757(21)2(01)00884838116757(21)91(01)00884838116757(21)33(01)00884838116757(21)34(01)00884838116757(21)48(01)00884838116757(21)46(01)00884838116757(21)23(01)00884838116757(21)43(01)00884838116757(21)36(01)00884838116757(21)96(01)00884838116757(21)95(01)00884838116757(21)10(01)00884838116757(21)76(01)00884838116757(21)42(01)00884838116757(21)6(01)00884838116757(21)77(01)00884838116757(21)3(01)00884838116757(21)1(01)00884838116757(21)56(01)00884838116757(21)51(01)00884838116757(21)44(01)00884838116757(21)30(01)00884838116757(21)29(01)00884838116757(21)28(01)00884838116757(21)102(01)00884838116757(21)19(01)00884838116757(21)8(01)00884838116757(21)81(01)00884838116757(21)20(01)00884838116757(21)16(01)00884838116757(21)11(01)00884838116757(21)112(01)00884838116757(21)63(01)00884838116757(21)68(01)00884838116757(21)32(01)00884838116757(21)35(01)00884838116757(21)122(01)00884838116757(21)14(01)00884838116757(21)82(01)00884838116757(21)13(01)00884838116757(21)50(01)00884838116757(21)57(01)00884838116757(21)58(01)00884838116757(21)4(01)00884838116757(21)105(01)00884838116757(21)75(01)00884838116757(21)121(01)00884838116757(21)120(01)00884838116757(21)71(01)00884838116757(21)72(01)00884838116757(21)73(01)00884838116757(21)70(01)00884838116757(21)69(01)00884838116757(21)37. 5
- Model Number722235
- UDI Numbers
72 of 72 codes
(01)00884838116788(21)88(01)00884838116788(21)43(01)00884838116788(21)12(01)00884838116788(21)102(01)00884838116788(21)127(01)00884838116788(21)57(01)00884838116788(21)55(01)00884838116788(21)11(01)00884838116788(21)76(01)00884838116788(21)71(01)00884838116788(21)59(01)00884838116788(21)77(01)00884838116788(21)89(01)00884838116788(21)56(01)00884838116788(21)99(01)00884838116788(21)30(01)00884838116788(21)84(01)00884838116788(21)82(01)00884838116788(21)83(01)00884838116788(21)93(01)00884838116788(21)31(01)00884838116788(21)47(01)00884838116788(21)3(01)00884838116788(21)13(01)00884838116788(21)10(01)00884838116788(21)74(01)00884838116788(21)98(01)00884838116788(21)40(01)00884838116788(21)81(01)00884838116788(21)66(01)00884838116788(21)63(01)00884838116788(21)67(01)00884838116788(21)64(01)00884838116788(21)42(01)00884838116788(21)65(01)00884838116788(21)58(01)00884838116788(21)53(01)00884838116788(21)52(01)00884838116788(21)49(01)00884838116788(21)44(01)00884838116788(21)35(01)00884838116788(21)45(01)00884838116788(21)39(01)00884838116788(21)25(01)00884838116788(21)34(01)00884838116788(21)17(01)00884838116788(21)24(01)00884838116788(21)19(01)00884838116788(21)33(01)00884838116788(21)18(01)00884838116788(21)9(01)00884838116788(21)28(01)00884838116788(21)8(01)00884838116788(21)23(01)00884838116788(21)21(01)00884838116788(21)6(01)00884838116788(21)7(01)00884838116788(21)5(01)00884838116788(21)108(01)00884838116788(21)109
- Model Number722236
- UDI Numbers
203 of 203 codes
(01)00884838116801(21)43(01)00884838116801(21)42(01)00884838116801(21)121(01)00884838116801(21)50(01)00884838116801(21)183(01)00884838116801(21)32(01)00884838116801(21)38(01)00884838116801(21)197(01)00884838116801(21)335(01)00884838116801(21)325(01)00884838116801(21)116(01)00884838116801(21)191(01)00884838116801(21)235(01)00884838116801(21)22(01)00884838116801(21)204(01)00884838116801(21)249(01)00884838116801(21)159(01)00884838116801(21)40(01)00884838116801(21)233(01)00884838116801(21)194(01)00884838116801(21)205(01)00884838116801(21)276(01)00884838116801(21)378(01)00884838116801(21)20(01)00884838116801(21)81(01)00884838116801(21)51(01)00884838116801(21)288(01)00884838116801(21)25(01)00884838116801(21)54(01)00884838116801(21)186(01)00884838116801(21)21(01)00884838116801(21)68(01)00884838116801(21)99(01)00884838116801(21)208(01)00884838116801(21)31(01)00884838116801(21)230(01)00884838116801(21)203(01)00884838116801(21)180(01)00884838116801(21)37(01)00884838116801(21)342(01)00884838116801(21)24(01)00884838116801(21)221(01)00884838116801(21)17(01)00884838116801(21)252(01)00884838116801(21)150(01)00884838116801(21)60(01)00884838116801(21)200(01)00884838116801(21)226(01)00884838116801(21)118(01)00884838116801(21)127(01)00884838116801(21)26(01)00884838116801(21)36(01)00884838116801(21)133(01)00884838116801(21)345(01)00884838116801(21)134(01)00884838116801(21)131(01)00884838116801(21)39(01)00884838116801(21)231(01)00884838116801(21)158(01)00884838116801(21)48
- Model Number722233
- UDI Numbers
154 of 154 codes
(01)00884838116764(21)118(01)00884838116764(21)96(01)00884838116764(21)259(01)00884838116764(21)169(01)00884838116764(21)108(01)00884838116764(21)212(01)00884838116764(21)267(01)00884838116764(21)214(01)00884838116764(21)147(01)00884838116764(21)153(01)00884838116764(21)111(01)00884838116764(21)122(01)00884838116764(21)124(01)00884838116764(21)127(01)00884838116764(21)59(01)00884838116764(21)172(01)00884838116764(21)64(01)00884838116764(21)170(01)00884838116764(21)41(01)00884838116764(21)103(01)00884838116764(21)144(01)00884838116764(21)219(01)00884838116764(21)218(01)00884838116764(21)192(01)00884838116764(21)30(01)00884838116764(21)189(01)00884838116764(21)186(01)00884838116764(21)17(01)00884838116764(21)9(01)00884838116764(21)245(01)00884838116764(21)57(01)00884838116764(21)32(01)00884838116764(21)203(01)00884838116764(21)205(01)00884838116764(21)204(01)00884838116764(21)184(01)00884838116764(21)162(01)00884838116764(21)18(01)00884838116764(21)83(01)00884838116764(21)84(01)00884838116764(21)88(01)00884838116764(21)76(01)00884838116764(21)137(01)00884838116764(21)85(01)00884838116764(21)86(01)00884838116764(21)87(01)00884838116764(21)46(01)00884838116764(21)47(01)00884838116764(21)26(01)00884838116764(21)234(01)00884838116764(21)200(01)00884838116764(21)250(01)00884838116764(21)201(01)00884838116764(21)123(01)00884838116764(21)235(01)00884838116764(21)68(01)00884838116764(21)14(01)00884838116764(21)82(01)00884838116764(21)27(01)00884838116764(21)38
- Model Number722234
- UDI Numbers
430 of 430 codes
(01)00884838116771(21)626(01)00884838116771(21)320(01)00884838116771(21)256(01)00884838116771(21)321(01)00884838116771(21)437(01)00884838116771(21)101(01)00884838116771(21)616(01)00884838116771(21)418(01)00884838116771(21)426(01)00884838116771(21)87(01)00884838116771(21)420(01)00884838116771(21)827(01)00884838116771(21)716(01)00884838116771(21)607(01)00884838116771(21)183(01)00884838116771(21)345(01)00884838116771(21)520(01)00884838116771(21)662(01)00884838116771(21)327(01)00884838116771(21)524(01)00884838116771(21)191(01)00884838116771(21)201(01)00884838116771(21)449(01)00884838116771(21)435(01)00884838116771(21)657(01)00884838116771(21)171(01)00884838116771(21)124(01)00884838116771(21)123(01)00884838116771(21)79(01)00884838116771(21)409(01)00884838116771(21)70(01)00884838116771(21)55(01)00884838116771(21)68(01)00884838116771(21)780(01)00884838116771(21)794(01)00884838116771(21)500(01)00884838116771(21)450(01)00884838116771(21)471(01)00884838116771(21)459(01)00884838116771(21)489(01)00884838116771(21)617(01)00884838116771(21)874(01)00884838116771(21)92(01)00884838116771(21)698(01)00884838116771(21)758(01)00884838116771(21)585(01)00884838116771(21)300(01)00884838116771(21)502(01)00884838116771(21)216(01)00884838116771(21)493(01)00884838116771(21)358(01)00884838116771(21)85(01)00884838116771(21)274(01)00884838116771(21)804(01)00884838116771(21)484(01)00884838116771(21)519(01)00884838116771(21)346(01)00884838116771(21)469(01)00884838116771(21)853(01)00884838116771(21)852
- Amount recalled
- 990 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
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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