Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System
This recall has been terminated (originally issued February 22, 2019).
- Recall Initiated
- December 21, 2018
- Posted
- February 22, 2019
- Terminated
- November 19, 2020
- Recall Number
- Z-0892-2019
- Quantity
- 11226 total
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
U.S. Nationwide distribution.
Lot / Code Info
All systems
Root Cause
Unknown/Undetermined by firm
Action Taken
Urgent Medical Device Correction notification letters dated December 2018 were sent to customers.
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