Z-2345-2019 Class II Terminated
FDA device recall Z-2345-2019 was initiated by Siemens Medical Solutions USA, Inc on July 9, 2019 and is designated Class II. Reason for recall: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. The recall status is terminated (terminated April 23, 2020). Affected quantity: 17.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- July 9, 2019
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
Product Description
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
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 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
Code Information
Serial # 66109 66111 166049 66047 166037 66102 66027 66053 66094 66028 66069 66092 66046 66082 166097 66044 166082