OmniDiagnost Eleva System codes 708028 708027
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-1490-2020
- Quantity
- 69
- 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
Serial codes 152 49 514 179 611 C@23273 46 560 555 464 14 90 198 15 326 143*003 451 267 FR90-111 417 59 390 164 135 23 143 80 219 24 78 73 15 79 109 624 71 44 576 70 460 62 98 63 620 147 100 68 122 422 12 54 490 97 138 20 130 67 ON100031011SN273 241 435 125 89 47 17 33 134 574
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.