—#179816

Product

Integris Allura 9, system codes 722018 722021

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K002016
Affected lot / code info: Serial Codes 8 114 64 906187 41 38 119 75 25 87 67 107 32 97

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Nationwide domestic distribution. Foreign distribution worldwide.

Timeline

Recall initiated: 2019-12-30
Terminated: 2022-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179816. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.