fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.
Recall
- Recall Number
- Z-2103-2018
- Event Number
- 78848
- Firm
- NordicNeuroLab AS Mollendalsveien 65c Bergen Norway
- FEI Number
- 3006738448
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 28, 2017
- Terminated
- March 31, 2021
Description
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
The firm notified the consignees by email on September 28, 2017. The units were to be returned. For further questions, please call 1 (855) 665-3674 option 1.
Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria
64 units