Device product

MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582

Z-2345-2019

July 09, 2019

Class II

Product summary

Firm: Siemens Medical Solutions USA, Inc
Event: Event 83415
Status: Terminated
Classification: Class II
Quantity: 17
Official record key: device-enforcement:Z-2345-2019

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 # 66109 66111 166049 66047 166037 66102 66027 66053 66094 66028 66069 66092 66046 66082 166097 66044 166082

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.