FDAFDA · Food and drugs·Recall number Z-1494-2020
Cardio Vascular-Allura Centron, system code 722400
Published March 25, 2020 · Recall initiated: December 30, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America, LLC
- Distributor
- Nationwide domestic distribution. Foreign distribution worldwide.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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