Integris Allura 9, system codes 722018 722021
FDA Recall #Z-1488-2020 — Class II — December 30, 2019
Product Description
Integris Allura 9, system codes 722018 722021
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.
Recalling Firm
Philips North America, LLC — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
20
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Code Information
Serial Codes 8 114 64 906187 41 38 119 75 25 87 67 107 32 97
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated