Recall Z-1493-2020
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
Allura CV20, system code 722031
Codes / lots: 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
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-1493-2020
- Initiated
- December 30, 2019
- Terminated
- November 17, 2022
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Quantity
- 128
- 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-1489-2020 Class II | MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038A 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-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 |