UroDiagnost Eleva, system code 708033
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-1492-2020
- Quantity
- 4
- 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 numbers 64 48 2 60
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.