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Recall Observatory FDA recall evidence

Device product

Allura CV20, system code 722031

Z-1493-2020

December 30, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 84756
Status
Terminated
Classification
Class II
Quantity
128
Official record key
device-enforcement:Z-1493-2020

Official wording

Reason: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

Code information: Not distributed in US. Serial numbers 155 42 150 160 87 154 29 73 88 48 109 78 53 63 41 97 138 86 39 36 152 135 40 49 80 153 91 23 35 64 71 55 33 32 30 75 76 70 133 124 182 173 101 128 21 115 81 82 19 84 92 166 72 69 22 26 61 130 52 98 116 117 110 113 112 111 89 90 177 164 165 161 162 163 28 100 174 56 167 119 168 185 50 120 151 125 131 159 126 79 66 137 65 123 169 122 121 148 147 146 149 140 38 129 184 127 181 178 62 170 132 157 158 134 46 136 96 180 45 47 99 54 31 175 83 77 94 85

Distribution pattern: Nationwide domestic distribution. Foreign distribution worldwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.