FDA recall Z-0695-2020

Product

Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

Reason for recall

In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure.

Distribution

US: WA and TX International: Denmark

Key facts

Status

Terminated

Initiation date

2019-11-14

Report date

2019-12-25

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0695-2020