Cardio Vascular-Allura Centron, system code 722400
This recall has been terminated (originally issued December 30, 2019).
- Company
- Philips North America, Llc
- Recall Initiated
- December 30, 2019
- Terminated
- November 17, 2022
- Recall Number
- Z-1494-2020
- Quantity
- 87
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Lot / Code Info
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
Root 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.