FDA Recall
Terminated
Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System
Recall: Z-0886-2019
·
Initiated December 21, 2018
Recall
- Recall Number
- Z-0886-2019
- Event Number
- 82038
- Firm
- Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands
- FEI Number
- 3002807880
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- December 21, 2018
- Posted
- February 22, 2019
- Terminated
- November 19, 2020
Description
Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System
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.
Action
Urgent Medical Device Correction notification letters dated December 2018 were sent to customers.
Distribution
U.S. Nationwide distribution.
Quantity
11226 total