Reported Jan 21, 2026 · Ongoing
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and…
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 with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models
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. |
- Lot codes and dates
- Software VersionsR2.1.10 and R2.2.10. 1
- Model Number (UDI)
273 of 273 codes
722063 ((01)00884838085275(21)122(01)00884838085275(21)64(01)00884838085275(21)56(01)00884838085275(21)131(01)00884838085275(21)84(01)00884838085275(21)132(01)00884838085275(21)96(01)00884838085275(21)98(01)00884838085275(21)108(01)00884838085275(21)153(01)00884838085275(21)69(01)00884838085275(21)154(01)00884838085275(21)97(01)00884838085275(21)137(01)00884838085275(21)116(01)00884838085275(21)127(01)00884838085275(21)151(01)00884838085275(21)148(01)00884838085275(21)150(01)00884838085275(21)146(01)00884838085275(21)149(01)00884838085275(21)123(01)00884838085275(21)130(01)00884838085275(21)143(01)00884838085275(21)139(01)00884838085275(21)144(01)00884838085275(21)145(01)00884838085275(21)141(01)00884838085275(21)140(01)00884838085275(21)135(01)00884838085275(21)133(01)00884838085275(21)107(01)00884838085275(21)120(01)00884838085275(21)129(01)00884838085275(21)105(01)00884838085275(21)110(01)00884838085275(21)128(01)00884838085275(21)119(01)00884838085275(21)113(01)00884838085275(21)43(01)00884838085275(21)117(01)00884838085275(21)115(01)00884838085275(21)101(01)00884838085275(21)94(01)00884838085275(21)106(01)00884838085275(21)103(01)00884838085275(21)99(01)00884838085275(21)102(01)00884838085275(21)104(01)00884838085275(21)100(01)00884838085275(21)80(01)00884838085275(21)81(01)00884838085275(21)89(01)00884838085275(21)86(01)00884838085275(21)90(01)00884838085275(21)91(01)00884838085275(21)92(01)00884838085275(21)75(01)00884838085275(21)82(01)00884838085275(21)87
- Model Number (UDI)
772 of 772 codes
722064 ((01)00884838085282(21)209(01)00884838085282(21)238(01)00884838085282(21)201(01)00884838085282(21)258(01)00884838085282(21)261(01)00884838085282(21)260(01)00884838085282(21)314(01)00884838085282(21)229(01)00884838085282(21)291(01)00884838085282(21)270(01)00884838085282(21)267(01)00884838085282(21)64(01)00884838085282(21)218(01)00884838085282(21)335(01)00884838085282(21)407(01)00884838085282(21)496(01)00884838085282(21)425(01)00884838085282(21)520(01)00884838085282(21)519(01)00884838085282(21)397(01)00884838085282(21)168(01)00884838085282(21)514(01)00884838085282(21)503(01)00884838085282(21)517(01)00884838085282(21)515(01)00884838085282(21)478(01)00884838085282(21)484(01)00884838085282(21)511(01)00884838085282(21)458(01)00884838085282(21)513(01)00884838085282(21)505(01)00884838085282(21)502(01)00884838085282(21)510(01)00884838085282(21)508(01)00884838085282(21)470(01)00884838085282(21)509(01)00884838085282(21)494(01)00884838085282(21)497(01)00884838085282(21)477(01)00884838085282(21)445(01)00884838085282(21)448(01)00884838085282(21)500(01)00884838085282(21)501(01)00884838085282(21)471(01)00884838085282(21)491(01)00884838085282(21)498(01)00884838085282(21)490(01)00884838085282(21)475(01)00884838085282(21)480(01)00884838085282(21)504(01)00884838085282(21)479(01)00884838085282(21)488(01)00884838085282(21)395(01)00884838085282(21)485(01)00884838085282(21)474(01)00884838085282(21)476(01)00884838085282(21)483(01)00884838085282(21)468(01)00884838085282(21)492(01)00884838085282(21)473
- Model Number (UDI)
170 of 170 codes
722227 ((01)00884838099227(21)265(01)00884838099227(21)135(01)00884838099227(21)88(01)00884838099227(21)276(01)00884838099227(21)264(01)00884838099227(21)63(01)00884838099227(21)238(01)00884838099227(21)360(01)00884838099227(21)322(01)00884838099227(21)336(01)00884838099227(21)356(01)00884838099227(21)353(01)00884838099227(21)342(01)00884838099227(21)338(01)00884838099227(21)345(01)00884838099227(21)344(01)00884838099227(21)284(01)00884838099227(21)326(01)00884838099227(21)362(01)00884838099227(21)351(01)00884838099227(21)208(01)00884838099227(21)340(01)00884838099227(21)348(01)00884838099227(21)352(01)00884838099227(21)306(01)00884838099227(21)335(01)00884838099227(21)332(01)00884838099227(21)350(01)00884838099227(21)331(01)00884838099227(21)355(01)00884838099227(21)330(01)00884838099227(21)334(01)00884838099227(21)346(01)00884838099227(21)333(01)00884838099227(21)297(01)00884838099227(21)339(01)00884838099227(21)337(01)00884838099227(21)324(01)00884838099227(21)321(01)00884838099227(21)101(01)00884838099227(21)313(01)00884838099227(21)89(01)00884838099227(21)323(01)00884838099227(21)329(01)00884838099227(21)318(01)00884838099227(21)319(01)00884838099227(21)175(01)00884838099227(21)311(01)00884838099227(21)320(01)00884838099227(21)308(01)00884838099227(21)301(01)00884838099227(21)247(01)00884838099227(21)315(01)00884838099227(21)305(01)00884838099227(21)316(01)00884838099227(21)272(01)00884838099227(21)286(01)00884838099227(21)258(01)00884838099227(21)300(01)00884838099227(21)307
- Amount recalled
- 10,466 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
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.
This product could cause temporary or reversible health problems — stop using it.
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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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