FDA recall Z-1245-2022

Siemens Medical Solutions USA, Inc · Class II · device

Product

Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

Reason for recall

if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2022-04-11
Report date
2022-06-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1245-2022