Device product
Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System
Z-0905-2019
Product summary
- Event
- Event 82038
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11226 total
- Official record key
device-enforcement:Z-0905-2019
Official wording
Reason: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Code information: All systems
Distribution pattern: U.S. Nationwide distribution.
Derived failure modes
-
Unknown
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.