FDA recall Z-1497-2020

Siemens Medical Solutions USA, Inc · Class II · device

Product

Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 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-1497-2020