Reported Apr 8, 2026 · Ongoing

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

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 5 M20
  • System Code
    • (1)722228
    • (2)722232
    • (3) 722281 (OUS only)
Lot codes and dates
  • (1)
  • System Code722228
  • UDI00884838099234
  • System Serial Number

    550 of 550 codes

    • 67
    • 524
    • 49
    • 678
    • 679
    • 10
    • 36
    • 64
    • 110
    • 403
    • 328
    • 481
    • 373
    • 149
    • 213
    • 45
    • 537
    • 615
    • 159
    • 18
    • 231
    • 180
    • 61
    • 204
    • 273
    • 538
    • 76
    • 502
    • 150
    • 132
    • 399
    • 533
    • 211
    • 17
    • 47
    • 38
    • 87
    • 617
    • 618
    • 619
    • 128
    • 522
    • 32
    • 600
    • 23
    • 25
    • 62
    • 177
    • 181
    • 48
    • 189
    • 153
    • 79
    • 80
    • 157
    • 24
    • 187
    • 26
    • 642
    • 431
  • System Code722232
  • UDI00884838116757
  • System Serial Number

    90 of 90 codes

    • 5
    • 33
    • 34
    • 106
    • 49
    • 138
    • 91
    • 2
    • 95
    • 96
    • 36
    • 23
    • 108
    • 42
    • 48
    • 46
    • 76
    • 6
    • 60
    • 61
    • 10
    • 43
    • 97
    • 8
    • 113
    • 118
    • 119
    • 139
    • 22
    • 50
    • 75
    • 63
    • 130
    • 132
    • 89
    • 86
    • 69
    • 3
    • 67
    • 39
    • 4
    • 44
    • 122
    • 123
    • 71
    • 72
    • 110
    • 93
    • 1
    • 68
    • 11
    • 77
    • 20
    • 7
    • 57
    • 58
    • 260
    • 115
    • 14
    • 82
  • System Code722281
  • UDI00884838110564
  • System Serial Number

    282 of 282 codes

    • 125
    • 176
    • 233
    • 296
    • 74
    • 284
    • 55
    • 81
    • 37
    • 21
    • 135
    • 278
    • 390
    • 179
    • 181
    • 182
    • 282
    • 286
    • 357
    • 358
    • 359
    • 109
    • 136
    • 93
    • 153
    • 247
    • 27
    • 28
    • 299
    • 76
    • 140
    • 60
    • 341
    • 310
    • 192
    • 275
    • 127
    • 108
    • 254
    • 255
    • 24
    • 20
    • 129
    • 343
    • 295
    • 215
    • 66
    • 98
    • 48
    • 235
    • 378
    • 145
    • 336
    • 115
    • 348
    • 120
    • 17
    • 12
    • 65
    • 217
Amount recalled
920 units (168 US, 752 OUS)

This recall covers 23 products

The agency filed one notice per product. You are reading one of them; the other 22 are below.

10 more are in the archive.

Where it was sold

  • Nationwide
  • GA

Why it was recalled

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.