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U.S. Department of Health and Human Services

Class 2 Device Recall Cardio Vascular Allura Centron Interventional fluoroscopic xray system

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  Class 2 Device Recall Cardio Vascular Allura Centron 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-1494-2020
Recall Event ID 84756
510(K)Number K141979  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Cardio Vascular-Allura Centron, system code 722400
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 
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 87
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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