Device product

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

Z-2343-2019

July 09, 2019

Class II

Product summary

Firm: Siemens Medical Solutions USA, Inc
Event: Event 83415
Status: Terminated
Classification: Class II
Quantity: 44
Official record key: device-enforcement:Z-2343-2019

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 # 46066 45732 46182 45735 45805 46171 45693 45886 45988 45881 46144 46044 46176 46179 46032 46238 145161 46127 45774 45968 46196 46175 45681 46007 46021 46105 46142 45928 45815 46150 145302 45878 46239 46026 145403 45667 145536 45970 45839 45982 46145 46298 45777 46294

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.