PlainRecalls
FDA Devices Moderate Class II Terminated

Integris Allura 9, system codes 722018 722021

Reported: March 25, 2020 Initiated: December 30, 2019 #Z-1488-2020

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.

Details

Units Affected
20
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
Integris Allura 9, system codes 722018 722021. Recalled by Philips North America, LLC. Units affected: 20.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1488-2020.