FDA recall Z-1495-2021

Product

Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137

Reason for recall

Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2021-03-26

Report date

2021-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1495-2021