FDA recall Z-2343-2019

Siemens Medical Solutions USA, Inc · Class II · device

Product

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

Reason for recall

Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.

Distribution

AL AR AZ CA CO CT DC DE FL GA GU IA ID IL IN KS KY LA MA MD ME MI MN MO MT NC NE NH NJ NY OH OK OR PA SC TN TX VA WA WI WV WY

Key facts

Status
Terminated
Initiation date
2019-07-09
Report date
2019-08-28
Termination date
2020-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2343-2019