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Recall Observatory FDA recall evidence

Device product

Cardio Vascular-Allura Centron, system code 722400

Z-1494-2020

December 30, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 84756
Status
Terminated
Classification
Class II
Quantity
87
Official record key
device-enforcement:Z-1494-2020

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 132 133 49 66 71 135 31 36 79 69 137 149 147 109 136 108 103 93 53 127 129 129 55 74 2 57 106 56 86 68 157 78 64 63 23 51 100 97 102 113 90 44 30 101 77 83 67 151 22 70 96 116 131 35 82 9 91 43 61 161 28 34 27 19 144 92 168 172 173 122 197 139 6 76 176 16 130 60 80 184 112 81 89 42 110 155 33

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.