Device product
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
Z-1770-2017
Product summary
- Event
- Event 76889
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 systems distributed in the U.S.
- Official record key
device-enforcement:Z-1770-2017
Official wording
Reason: Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.
Code information: Model Number: 10684336, 10684337 Serial Number: 12811002 12811003 12811017
Distribution pattern: US Distribution to: DC and MD.
Derived failure modes
-
Manufacturing or process control
manufacturing error