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U.S. Department of Health and Human Services

Class 2 Device Recall Allura CV20 Interventional fluoroscopic xray system

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  Class 2 Device Recall Allura CV20 Interventional fluoroscopic xray system see related information
Date Initiated by Firm December 30, 2019
Create Date March 13, 2020
Recall Status1 Terminated 3 on November 17, 2022
Recall Number Z-1493-2020
Recall Event ID 84756
510(K)Number K141979  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Allura CV20, system code 722031
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 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Technical Support Line
800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action On December 30, 2019, the firm notified customers via Medical Device Correction letter. Customers were informed of the product issue and advised to do the following: If the capacitor of the Velara X-Ray fails as described (capacitor failure after large number of surges in a short period of time), please switch off the system, take it out of service immediately, and contact your local Philips representative. The firm will be resolving the issue by replacing a Printed Circuit Board (PCB) in the convertor, which prevents the capacitor from failing. PCB replacements started in January 2020. Customers will be contacted by their local Philips representatives to schedule a date for the PCB replacement. Customers with further questions should contact the Technical Support Line: 1-800-722-9377.
Quantity in Commerce 128
Distribution Nationwide domestic distribution. Foreign distribution worldwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
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