Poly G Integris H5000, System code 72246
Recall
- Recall Number
- Z-1491-2020
- Event Number
- 84756
- Firm
- Philips North America, LLC
- FEI Number
- 1218950
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- December 30, 2019
- Terminated
- November 17, 2022
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032
Description
Poly G Integris H5000, System code 72246
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.
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.
Nationwide domestic distribution. Foreign distribution worldwide.
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