Device product

MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643

Z-2344-2019

July 09, 2019

Class II

Product summary

Firm: Siemens Medical Solutions USA, Inc
Event: Event 83415
Status: Terminated
Classification: Class II
Quantity: 2
Official record key: device-enforcement:Z-2344-2019

Official wording

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

Code information: Serial # 72030 72023

Distribution pattern: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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