FDA recall Z-1488-2020

Product

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.

Distribution

Nationwide domestic distribution. Foreign distribution worldwide.

Key facts

Status

Terminated

Initiation date

2019-12-30

Report date

2020-03-25

Termination date

2022-11-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2020