FDA recall Z-1496-2020

Product

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Reason for recall

A software issue could potentially cause the stand and table movements to be blocked.

Distribution

US Nationwide distribuiton.

Key facts

Status

Terminated

Initiation date

2020-02-14

Report date

2020-03-25

Termination date

2021-04-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1496-2020