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Terminated

Cardio Vascular-Allura Centron, system code 722400

FDA Recall Z-1494-2020 · Posted None

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeOWB
Date Initiated2019-12-30
Date Terminated2022-11-17
Product Quantity87

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.

Firm Action

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.

Root Cause

Component design/selection

Distribution Pattern

Nationwide domestic distribution. Foreign distribution worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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