FDA recall Z-1486-2020

Product

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

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-1486-2020