Cardio Vascular-Allura Centron, system code 722400
FDA Recall #Z-1494-2020 — Class II — December 30, 2019
Product Description
Cardio Vascular-Allura Centron, system code 722400
Reason for Recall
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.
Recalling Firm
Philips North America, LLC — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
87
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated