Reported Apr 8, 2026 · Ongoing

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

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 3 M12
  • System Code
    • (1)722063
    • (2)722221
    • (3)722229
Lot codes and dates
  • (1)
  • System Code722063
  • UDI00884838085275
  • System Serial Number

    110 of 110 codes

    • 122
    • 56
    • 64
    • 131
    • 84
    • 132
    • 96
    • 98
    • 108
    • 77
    • 82
    • 145
    • 47
    • 146
    • 80
    • 102
    • 43
    • 117
    • 2
    • 149
    • 99
    • 44
    • 3
    • 28
    • 144
    • 62
    • 119
    • 61
    • 22
    • 29
    • 153
    • 40
    • 70
    • 30
    • 25
    • 19
    • 120
    • 121
    • 110
    • 14
    • 16
    • 17
    • 53
    • 103
    • 127
    • 97
    • 143
    • 41
    • 104
    • 116
    • 151
    • 93
    • 141
    • 115
    • 137
    • 73
    • 150
    • 128
    • 105
    • 4
  • System Code722221
  • UDI00884838085275
  • System Serial Number

    163 of 163 codes

    • 181
    • 3
    • 7
    • 178
    • 54
    • 6
    • 93
    • 69
    • 9
    • 115
    • 177
    • 85
    • 19
    • 49
    • 171
    • 153
    • 108
    • 193
    • 104
    • 169
    • 45
    • 101
    • 135
    • 106
    • 51
    • 114
    • 36
    • 124
    • 197
    • 129
    • 4
    • 154
    • 146
    • 68
    • 195
    • 130
    • 183
    • 187
    • 42
    • 172
    • 164
    • 190
    • 151
    • 71
    • 152
    • 184
    • 147
    • 32
    • 105
    • 182
    • 58
    • 103
    • 149
    • 127
    • 128
    • 86
    • 122
    • 60
    • 155
    • 66
  • System Code722229
  • UDI00884838085275
  • System Serial Number
    • 22
    • 9
    • 40
    • 7
    • 24
    • 35
    • 16
    • 15
    • 41
    • 5
    • 3
    • 29
    • 4
    • 38
    • 33
    • 32
    • 6
    • 2
    • 20
    • 26
    • 31
    • 10
    • 11
    • 21
    • 25
    • 13
    • 8
Amount recalled
298 units (27 US, 271 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?

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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 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.