Philips North America, LLC Poly G Integris H5000, System code 72246 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Poly G Integris H5000, System code 72246
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
System equipment number 519212
Products Sold
System equipment number 519212
Philips North America, LLC is recalling Poly G Integris H5000, System code 72246 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026