Reported Jun 3, 2026 · Ongoing

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064,…

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
- 722221)
- Azurion 3 M15 (722064
- 722222)
- Azurion 5 M12 (722227)
- Azurion 5 M20 (722228)
- Azurion 7 B12 (722067
- 722225)
- Azurion 7 B20 (722068
- 722226)
- Azurion 7 M12 (722078
- 722223)
- Azurion 7 M20 (722079
- 722224)

Lot codes and dates: 1. Azurion 3 M12
Model722063
UDI
101 of 101 codes
(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)98
(01)00884838085275(21)108
(01)00884838085275(21)77
(01)00884838085275(21)82
(01)00884838085275(21)47
(01)00884838085275(21)80
(01)00884838085275(21)146
(01)00884838085275(21)102
(01)00884838085275(21)117
(01)00884838085275(21)2
(01)00884838085275(21)149
(01)00884838085275(21)99
(01)00884838085275(21)44
(01)00884838085275(21)3
(01)00884838085275(21)28
(01)00884838085275(21)144
(01)00884838085275(21)62
(01)00884838085275(21)119
(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)120
(01)00884838085275(21)121
(01)00884838085275(21)110
(01)00884838085275(21)16
(01)00884838085275(21)14
(01)00884838085275(21)17
(01)00884838085275(21)53
(01)00884838085275(21)103
(01)00884838085275(21)101
(01)00884838085275(21)143
(01)00884838085275(21)41
(01)00884838085275(21)104
(01)00884838085275(21)116
(01)00884838085275(21)151
(01)00884838085275(21)93
(01)00884838085275(21)141
(01)00884838085275(21)115
(01)00884838085275(21)73
(01)00884838085275(21)150
(01)00884838085275(21)128
(01)00884838085275(21)105
(01)00884838085275(21)4
(01)00884838085275(21)50
(01)00884838085275(21)129
(01)00884838085275(21)72
(01)00884838085275(21)38
(01)00884838085275(21)21
(01)00884838085275(21)78
Model722221
UDI
(01)00884838099203(21)3
(01)00884838099203(21)7
(01)00884838099203(21)6
(01)00884838099203(21)9
(01)00884838099203(21)4
(01)00884838099203(21)23
(01)00884838099203(21)26
(01)00884838099203(21)15
(01)00884838099203(21)2
(01)00884838099203(21)5
(01)00884838099203(21)1
(01)00884838099203(21)11
3. Azurion 3 M15
Model722064
UDI
229 of 229 codes
(01)00884838085282(21)209
(01)00884838085282(21)238
(01)00884838085282(21)201
(01)00884838085282(21)258
(01)00884838085282(21)260
(01)00884838085282(21)261
(01)00884838085282(21)314
(01)00884838085282(21)229
(01)00884838085282(21)291
(01)00884838085282(21)270
(01)00884838085282(21)267
(01)00884838085282(21)218
(01)00884838085282(21)61
(01)00884838085282(21)162
(01)00884838085282(21)161
(01)00884838085282(21)297
(01)00884838085282(21)169
(01)00884838085282(21)131
(01)00884838085282(21)190
(01)00884838085282(21)268
(01)00884838085282(21)220
(01)00884838085282(21)173
(01)00884838085282(21)256
(01)00884838085282(21)290
(01)00884838085282(21)89
(01)00884838085282(21)303
(01)00884838085282(21)157
(01)00884838085282(21)130
(01)00884838085282(21)263
(01)00884838085282(21)60
(01)00884838085282(21)264
(01)00884838085282(21)253
(01)00884838085282(21)254
(01)00884838085282(21)257
(01)00884838085282(21)280
(01)00884838085282(21)9
(01)00884838085282(21)277
(01)00884838085282(21)102
(01)00884838085282(21)137
(01)00884838085282(21)84
(01)00884838085282(21)78
(01)00884838085282(21)49
(01)00884838085282(21)193
(01)00884838085282(21)271
(01)00884838085282(21)185
(01)00884838085282(21)214
(01)00884838085282(21)212
(01)00884838085282(21)266
(01)00884838085282(21)213
(01)00884838085282(21)180
(01)00884838085282(21)250
(01)00884838085282(21)186
(01)00884838085282(21)246
(01)00884838085282(21)282
(01)00884838085282(21)354
(01)00884838085282(21)274
(01)00884838085282(21)127
(01)00884838085282(21)106
(01)00884838085282(21)276
(01)00884838085282(21)58
Model722222
UDI
(01)00884838099210(21)12
(01)00884838099210(21)15
(01)00884838099210(21)19
(01)00884838099210(21)23
(01)00884838099210(21)17
(01)00884838099210(21)35
(01)00884838099210(21)21
(01)00884838099210(21)18
(01)00884838099210(21)24
(01)00884838099210(21)9
(01)00884838099210(21)5
(01)00884838099210(21)14
(01)00884838099210(21)10
(01)00884838099210(21)13
5. Azurion 5 M12
Model722227
UDI
(01)00884838099227(21)23
(01)00884838099227(21)19
(01)00884838099227(21)5
(01)00884838099227(21)6
(01)00884838099227(21)7
(01)00884838099227(21)36
(01)00884838099227(21)18
(01)00884838099227(21)15
(01)00884838099227(21)14
(01)00884838099227(21)17
(01)00884838099227(21)2
(01)00884838099227(21)1
(01)00884838099227(21)12
(01)00884838099227(21)3
(01)00884838099227(21)11
(01)00884838099227(21)13
(01)00884838099227(21)4
6. Azurion 5 M20
Model722228
UDI
(01)00884838099234(21)10
(01)00884838099234(21)18
(01)00884838099234(21)23
(01)00884838099234(21)3
(01)00884838099234(21)16
(01)00884838099234(21)22
(01)00884838099234(21)4
(01)00884838099234(21)12
(01)00884838099234(21)14
(01)00884838099234(21)7
(01)00884838099234(21)5
7. Azurion 7 B12
Model722067
UDI
188 of 188 codes
(01)00884838085350(21)42
(01)00884838085350(21)172
(01)00884838085350(21)173
(01)00884838085350(21)109
(01)00884838085350(21)250
(01)00884838085350(21)103
(01)00884838085350(21)192
(01)00884838085350(21)92
(01)00884838085350(21)114
(01)00884838085350(21)225
(01)00884838085350(21)69
(01)00884838085350(21)214
(01)00884838085350(21)41
(01)00884838085350(21)221
(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)147
(01)00884838085350(21)132
(01)00884838085350(21)244
(01)00884838085350(21)104
(01)00884838085350(21)208
(01)00884838085350(21)36
(01)00884838085350(21)234
(01)00884838085350(21)141
(01)00884838085350(21)70
(01)00884838085350(21)26
(01)00884838085350(21)148
(01)00884838085350(21)133
(01)00884838085350(21)57
(01)00884838085350(21)128
(01)00884838085350(21)188
(01)00884838085350(21)151
(01)00884838085350(21)68
(01)00884838085350(21)233
(01)00884838085350(21)111
(01)00884838085350(21)255
(01)00884838085350(21)43
(01)00884838085350(21)33
(01)00884838085350(21)22
(01)00884838085350(21)146
(01)00884838085350(21)270
(01)00884838085350(21)238
(01)00884838085350(21)187
(01)00884838085350(21)74
(01)00884838085350(21)154
(01)00884838085350(21)157
(01)00884838085350(21)251
(01)00884838085350(21)237
(01)00884838085350(21)222
(01)00884838085350(21)262
(01)00884838085350(21)29
(01)00884838085350(21)59
Model722225
UDI
(01)00884838099265(21)29
(01)00884838099265(21)8
(01)00884838099265(21)38
(01)00884838099265(21)14
(01)00884838099265(21)243
(01)00884838099265(21)4
(01)00884838099265(21)30
(01)00884838099265(21)7
(01)00884838099265(21)17
(01)00884838099265(21)31
(01)00884838099265(21)32
(01)00884838099265(21)18
(01)00884838099265(21)19
(01)00884838099265(21)10
(01)00884838099265(21)35
(01)00884838099265(21)36
(01)00884838099265(21)15
(01)00884838099265(21)11
(01)00884838099265(21)21
(01)00884838099265(21)16
(01)00884838099265(21)27
(01)00884838099265(21)12
(01)00884838099265(21)9
9. Azurion 7 B20
Model722068
UDI
348 of 348 codes
(01)00884838085367(21)467
(01)00884838085367(21)178
(01)00884838085367(21)335
(01)00884838085367(21)147
(01)00884838085367(21)205
(01)00884838085367(21)170
(01)00884838085367(21)494
(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)153
(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)407
(01)00884838085367(21)239
(01)00884838085367(21)505
(01)00884838085367(21)271
(01)00884838085367(21)443
(01)00884838085367(21)104
(01)00884838085367(21)370
(01)00884838085367(21)322
(01)00884838085367(21)136
(01)00884838085367(21)373
(01)00884838085367(21)442
(01)00884838085367(21)308
(01)00884838085367(21)354
(01)00884838085367(21)75
(01)00884838085367(21)279
(01)00884838085367(21)196
(01)00884838085367(21)510
(01)00884838085367(21)110
(01)00884838085367(21)446
(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)528
(01)00884838085367(21)329
(01)00884838085367(21)184
(01)00884838085367(21)350
(01)00884838085367(21)304
(01)00884838085367(21)470
(01)00884838085367(21)457
(01)00884838085367(21)472
(01)00884838085367(21)319
(01)00884838085367(21)520
(01)00884838085367(21)490
(01)00884838085367(21)243
(01)00884838085367(21)103
(01)00884838085367(21)261
(01)00884838085367(21)262
Model722226
UDI
62 of 62 codes
(01)00884838099272(21)108
(01)00884838099272(21)117
(01)00884838099272(21)78
(01)00884838099272(21)11
(01)00884838099272(21)59
(01)00884838099272(21)75
(01)00884838099272(21)19
(01)00884838099272(21)141
(01)00884838099272(21)21
(01)00884838099272(21)60
(01)00884838099272(21)61
(01)00884838099272(21)10
(01)00884838099272(21)142
(01)00884838099272(21)99
(01)00884838099272(21)36
(01)00884838099272(21)5
(01)00884838099272(21)14
(01)00884838099272(21)45
(01)00884838099272(21)97
(01)00884838099272(21)18
(01)00884838099272(21)47
(01)00884838099272(21)1
(01)00884838099272(21)194
(01)00884838099272(21)29
(01)00884838099272(21)50
(01)00884838099272(21)16
(01)00884838099272(21)82
(01)00884838099272(21)55
(01)00884838099272(21)6
(01)00884838099272(21)7
(01)00884838099272(21)53
(01)00884838099272(21)52
(01)00884838099272(21)63
(01)00884838099272(21)26
(01)00884838099272(21)69
(01)00884838099272(21)42
(01)00884838099272(21)115
(01)00884838099272(21)43
(01)00884838099272(21)73
(01)00884838099272(21)70
(01)00884838099272(21)128
(01)00884838099272(21)40
(01)00884838099272(21)137
(01)00884838099272(21)110
(01)00884838099272(21)68
(01)00884838099272(21)64
(01)00884838099272(21)49
(01)00884838099272(21)38
(01)00884838099272(21)33
(01)00884838099272(21)30
(01)00884838099272(21)92
(01)00884838099272(21)62
(01)00884838099272(21)34
(01)00884838099272(21)71
(01)00884838099272(21)91
(01)00884838099272(21)35
(01)00884838099272(21)31
(01)00884838099272(21)56
(01)00884838099272(21)28
(01)00884838099272(21)79
Model722078
UDI
207 of 207 codes
(01)00884838085251(21)302
(01)00884838085251(21)585
(01)00884838085251(21)410
(01)00884838085251(21)753
(01)00884838085251(21)523
(01)00884838085251(21)293
(01)00884838085251(21)840
(01)00884838085251(21)291
(01)00884838085251(21)536
(01)00884838085251(21)537
(01)00884838085251(21)870
(01)00884838085251(21)613
(01)00884838085251(21)598
(01)00884838085251(21)679
(01)00884838085251(21)224
(01)00884838085251(21)829
(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)437
(01)00884838085251(21)438
(01)00884838085251(21)456
(01)00884838085251(21)833
(01)00884838085251(21)566
(01)00884838085251(21)488
(01)00884838085251(21)550
(01)00884838085251(21)327
(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)921
(01)00884838085251(21)700
(01)00884838085251(21)165
(01)00884838085251(21)445
(01)00884838085251(21)539
(01)00884838085251(21)657
(01)00884838085251(21)656
(01)00884838085251(21)658
(01)00884838085251(21)654
(01)00884838085251(21)436
(01)00884838085251(21)862
(01)00884838085251(21)786
(01)00884838085251(21)308
(01)00884838085251(21)396
(01)00884838085251(21)576
(01)00884838085251(21)121
(01)00884838085251(21)239
(01)00884838085251(21)383
(01)00884838085251(21)491
(01)00884838085251(21)125
(01)00884838085251(21)500
(01)00884838085251(21)645
(01)00884838085251(21)379
(01)00884838085251(21)399
Amount recalled: 3069 units (872 US, 2224 OUS)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Allura system

Where it was sold

Nationwide
GA

Why it was recalled

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

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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