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.
Reported: June 13, 2018 Initiated: October 28, 2017 #Z-2103-2018
Product 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.
Reason for Recall
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Details
- Recalling Firm
- NordicNeuroLab AS
- Units Affected
- 64 units
- Distribution
- 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
- Location
- Bergen, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by NordicNeuroLab AS. Units affected: 64 units.
Why was this product recalled? ▼
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2103-2018.
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