FDA recall Z-2257-2020

Product

ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

Reason for recall

Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient

Distribution

AZ, IL, UT, WI

Key facts

Status

Terminated

Initiation date

2020-04-23

Report date

2020-06-10

Termination date

2020-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2257-2020