Reported Nov 4, 2026 · Ongoing
Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
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?
- Philips Azurion 3 M15
- Model Number
722064722222722280
- Lot codes and dates
- 1
- Model Number722064
- UDI Numbers
260 of 260 codes
(01)00884838085282(21)258(01)00884838085282(21)229(01)00884838085282(21)291(01)00884838085282(21)64(01)00884838085282(21)218(01)00884838085282(21)335(01)00884838085282(21)161(01)00884838085282(21)169(01)00884838085282(21)297(01)00884838085282(21)479(01)00884838085282(21)190(01)00884838085282(21)268(01)00884838085282(21)220(01)00884838085282(21)375(01)00884838085282(21)173(01)00884838085282(21)359(01)00884838085282(21)256(01)00884838085282(21)290(01)00884838085282(21)502(01)00884838085282(21)130(01)00884838085282(21)157(01)00884838085282(21)264(01)00884838085282(21)60(01)00884838085282(21)263(01)00884838085282(21)253(01)00884838085282(21)254(01)00884838085282(21)280(01)00884838085282(21)9(01)00884838085282(21)102(01)00884838085282(21)467(01)00884838085282(21)421(01)00884838085282(21)510(01)00884838085282(21)345(01)00884838085282(21)212(01)00884838085282(21)266(01)00884838085282(21)180(01)00884838085282(21)185(01)00884838085282(21)193(01)00884838085282(21)214(01)00884838085282(21)271(01)00884838085282(21)213(01)00884838085282(21)431(01)00884838085282(21)246(01)00884838085282(21)354(01)00884838085282(21)374(01)00884838085282(21)106(01)00884838085282(21)58(01)00884838085282(21)231(01)00884838085282(21)287(01)00884838085282(21)44(01)00884838085282(21)176(01)00884838085282(21)149(01)00884838085282(21)197(01)00884838085282(21)289(01)00884838085282(21)288(01)00884838085282(21)150(01)00884838085282(21)233(01)00884838085282(21)230(01)00884838085282(21)380(01)00884838085282(21)448
- Serial Numbers
260 of 260 codes
258229291642183351611692974791902682203751733592562905021301572646026325325428091024674215103452122661801851932142712134312463543741065823128744176149197289288150233230380448
- Model Number722222
- UDI Numbers
134 of 134 codes
(01)00884838099210(21)226(01)00884838099210(21)55(01)00884838099210(21)44(01)00884838099210(21)262(01)00884838099210(21)37(01)00884838099210(21)318(01)00884838099210(21)395(01)00884838099210(21)269(01)00884838099210(21)304(01)00884838099210(21)316(01)00884838099210(21)307(01)00884838099210(21)320(01)00884838099210(21)344(01)00884838099210(21)343(01)00884838099210(21)230(01)00884838099210(21)340(01)00884838099210(21)346(01)00884838099210(21)174(01)00884838099210(21)338(01)00884838099210(21)345(01)00884838099210(21)362(01)00884838099210(21)323(01)00884838099210(21)336(01)00884838099210(21)339(01)00884838099210(21)308(01)00884838099210(21)182(01)00884838099210(21)390(01)00884838099210(21)56(01)00884838099210(21)312(01)00884838099210(21)368(01)00884838099210(21)172(01)00884838099210(21)151(01)00884838099210(21)138(01)00884838099210(21)141(01)00884838099210(21)384(01)00884838099210(21)224(01)00884838099210(21)386(01)00884838099210(21)383(01)00884838099210(21)351(01)00884838099210(21)88(01)00884838099210(21)210(01)00884838099210(21)372(01)00884838099210(21)89(01)00884838099210(21)373(01)00884838099210(21)361(01)00884838099210(21)102(01)00884838099210(21)118(01)00884838099210(21)119(01)00884838099210(21)209(01)00884838099210(21)331(01)00884838099210(21)145(01)00884838099210(21)108(01)00884838099210(21)48(01)00884838099210(21)4(01)00884838099210(21)305(01)00884838099210(21)80(01)00884838099210(21)83(01)00884838099210(21)47(01)00884838099210(21)222(01)00884838099210(21)389
- Serial Numbers
134 of 134 codes
226554426237318395269304316307320344343230340346174338345362323336339308182390563123681721511381413842243863833518821037289373361102118119209331145108484305808347222389
- Model Number722280
- UDI Numbers
125 of 125 codes
(01)00884838103276(21)43(01)00884838103276(21)179(01)00884838103276(21)229(01)00884838103276(21)249(01)00884838103276(21)65(01)00884838103276(21)76(01)00884838103276(21)232(01)00884838103276(21)113(01)00884838103276(21)167(01)00884838103276(21)290(01)00884838103276(21)165(01)00884838103276(21)80(01)00884838103276(21)128(01)00884838103276(21)278(01)00884838103276(21)44(01)00884838103276(21)240(01)00884838103276(21)246(01)00884838103276(21)295(01)00884838103276(21)66(01)00884838103276(21)175(01)00884838103276(21)34(01)00884838103276(21)79(01)00884838103276(21)130(01)00884838103276(21)48(01)00884838103276(21)52(01)00884838103276(21)141(01)00884838103276(21)131(01)00884838103276(21)189(01)00884838103276(21)223(01)00884838103276(21)87(01)00884838103276(21)139(01)00884838103276(21)259(01)00884838103276(21)218(01)00884838103276(21)188(01)00884838103276(21)30(01)00884838103276(21)96(01)00884838103276(21)171(01)00884838103276(21)118(01)00884838103276(21)280(01)00884838103276(21)21(01)00884838103276(21)284(01)00884838103276(21)220(01)00884838103276(21)133(01)00884838103276(21)38(01)00884838103276(21)243(01)00884838103276(21)69(01)00884838103276(21)210(01)00884838103276(21)127(01)00884838103276(21)222(01)00884838103276(21)144(01)00884838103276(21)142(01)00884838103276(21)143(01)00884838103276(21)198(01)00884838103276(21)253(01)00884838103276(21)71(01)00884838103276(21)241(01)00884838103276(21)152(01)00884838103276(21)247(01)00884838103276(21)17(01)00884838103276(21)260
- Serial Numbers
125 of 125 codes
431792292496576232113167290165801282784424024629566175347913048521411311892238713925921818830961711182802128422013338243692101272221441421431982537124115224717260
- Amount recalled
- 519 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
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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