—#179834

Product

Allura CV20, system code 722031

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141979
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Nationwide domestic distribution. Foreign distribution worldwide.

Timeline

Recall initiated: 2019-12-30
Terminated: 2022-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179834. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.