Device product
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
Z-1598-2016
Product summary
- Event
- Event 73947
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 systems
- Official record key
device-enforcement:Z-1598-2016
Official wording
Reason: The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.
Code information: Model # 10432914 and 10432915 Serial Numbers: 42472, 42489, 42477, 46169, 46178, 46175, 42478, 42485
Distribution pattern: US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.
Derived failure modes
-
Unknown
The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.