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U.S. Department of Health and Human Services

Class 2 Device Recall MultiDiagnost Eleva System, xray, angiographic

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 Class 2 Device Recall MultiDiagnost Eleva System, xray, angiographicsee related information
Date Initiated by FirmDecember 30, 2019
Create DateMarch 13, 2020
Recall Status1 Terminated 3 on November 17, 2022
Recall NumberZ-1489-2020
Recall Event ID 84756
510(K)NumberK023441 K050151 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductMultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Code Information Serial Codes  32 177 98 18 42 40 239 228 123 235 152 107  90 26 239 272 88 258 52 111 67 111  85 257 46 94 129 142 121 172 191 41 143 185 36 129 32 81 136 120 159 236 114 113 181 109 124 244 238 23 82 65 57 91 15A 249 259 74 207 101 182 101 174 70 124 34  138 188 142 86 35 37 128 47 118 4 178 158 172 27 43 117 148 149 10 45 203 79  47 229 151  7 5 24 64 184 183 76 173 58 199 29 119 34 407 126 524617 152 188 71 52 60 242 244 52 393 346 49 102 47 197 198 34 147 87 134 178 237 105 176 190 241 397 36 245 13 187 175 38 162 107 76 220 65 15 26 194 81 126 217 69 124 184 107 139 35 13 15 373 66 215 78 241 25 50 112 150 86 230 22 42 145 12 207 206 29 139 98 222 146 79 29 151 111 158 61 33 106 190 35 50 17 16 80 59 S01H044631 S01H055478 METRA01139 4.5161E+15 62 70 228 376 77 8 76 59 88 48 205 161 155 11 204 37 4 12 233 30 189 92 9 232 221 30 411 31 14 15 228 163 201 155 91 55 69 44 47 200 205 171 48 40 213 209 19 218 95 96 18 123 266 34 URF.213 CV.793 90 212 URF.173 171 217 URF.175 87 88 110 181 175 72 163 140 121 174 9 43 114 115 160 23 71 141 28 16 202 209 50 14 144 36 141 156 45 708032/14 193 224 72 164 93 98 25 105 57 110 216 138 24 28 74  35 211 185 108 160 192 189 118 43 44 157 154 41 218 153 33 48 219 8 104 53 68 129 75 221 177 146 116 68 38 64 196 7 49 63 37 24 181 10 63 125 251 180 164 240 135 21 340 343 183 01H042957/78 84267 8 26 125 193 17 125 170 210 54 1 161 113 60 90 132 36 24 81 22 23 208 6 131  27 135 42 88 5 226 6 150 156 73 483 183 731000268 246 133 621009 214 83 01H034592 84 01H044355 192 49 149 169 92 93 91 424 62 201 250 61 251 191 195 365 100 227 236 217 97 99 101 102 229 219 103 44 226 46 173 72 129 71 89 95 215 148 140 2 36 20 80 237 32 172 5 39 51 12 94 176 212 179 31 2 25  96 154 30 51 100 43 63 4 255 182 252 256 109 157 85 196 164 200 170 227 234 173 83 19 132 159 21 116 49 21 53 165 13 120 159 11 41 137 62 10 116 106 56 118 55 7 3 8 366 106 114 108 213 268 293 119 14 167 169 168 115 107 54 31 97 112 188 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactTechnical 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
ActionOn 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 Commerce534
DistributionNationwide domestic distribution. Foreign distribution worldwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZI
510(K)s with Product Code = IZI
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