Reported Apr 3, 2019 · Terminated

URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional,…

Philips North America, LLC

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 North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

    • URODiagnost Eleva
    • Product codes 708026
    • 708027
    • 708028
  • Product UsageThe Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations
  • and interventional procedures includeGastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and
  • non-subtracted digital imagingincludeAngiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures
Lot codes and dates
  • Serial numbers 1 2 3 4 5 6 8 11 12 12 13 13 14 15 15 16 16 17 17 18 19 20 21 22 22 23 23 24 24 25 26 27 28 29 29 30 30 32 32 33 33 34 34 35 35 36 36 37 37 38 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 54 55 57 58 59 60 61 62 63 64 65 67 68 69 70 71 72 73 76 77 78 79 80 82 83 84 85 86 88 89 90 91 94 96 97 98

    402 of 402 codes

    • 100
    • 101
    • 102
    • 103
    • 105
    • 106
    • 107
    • 108
    • 109
    • 110
    • 111
    • 112
    • 113
    • 114
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    • 117
    • 118
    • 119
    • 120
    • 121
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    • 123
    • 124
    • 125
    • 126
    • 128
    • 129
    • 130
    • 131
    • 133
    • 134
    • 135
    • 136
    • 138
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    • 140
    • 141
    • 143
    • 144
    • 145
    • 147
    • 148
    • 151
    • 152
    • 153
    • 154
    • 155
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    • 157
    • 158
    • 159
    • 160
    • 163
    • 164
    • 165
    • 166
    • 167
    • 168
    • 169
    • 170
Amount recalled
1969

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.

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

Notice updated Aug 3, 2020 · Data as of Sep 19, 5:36 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.