Poly G Integris H5000, System code 72246
FDA Recall #Z-1491-2020 — Class II — December 30, 2019
Product Description
Poly G Integris H5000, System code 72246
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
1
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Code Information
System equipment number 519212
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated