Recall Z-1489-2020
Philips North America, LLC · initiated December 30, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Codes / lots: 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…
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: Component design/selection
Action taken
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.
Details
- Recall number
- Z-1489-2020
- Initiated
- December 30, 2019
- Terminated
- November 17, 2022
- Product code
- IZI – System, X-Ray, Angiographic
- Quantity
- 534
- Distribution
- Nationwide domestic distribution. Foreign distribution worldwide.
- Recalling firm
- Philips North America, LLC, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1486-2020 Class II | Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001…A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1487-2020 Class II | Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1488-2020 Class II | Integris Allura 9, system codes 722018 722021A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1490-2020 Class II | OmniDiagnost Eleva System codes 708028 708027A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1491-2020 Class II | Poly G Integris H5000, System code 72246A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1492-2020 Class II | UroDiagnost Eleva, system code 708033A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1493-2020 Class II | Allura CV20, system code 722031A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1494-2020 Class II | Cardio Vascular-Allura Centron, system code 722400A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |