Z-3023-2018 Class II Terminated
FDA device recall Z-3023-2018 was initiated by NordicNeuroLab AS on August 20, 2018 and is designated Class II. Reason for recall: Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner). The recall status is terminated (terminated September 16, 2020). Affected quantity: 163 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 19, 2018
- Initiation Date
- August 20, 2018
- Termination Date
- September 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163 units
Product Description
fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1
Reason for Recall
Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).
Distribution Pattern
worldwide
Code Information
Serial numbers: LPS-2011-1.0-XXX LPS-2012-1.0-XXX LPS-2012-1.1-XXX LPS-2013-1.1-XXX