fMRI Hardware System - AudioSystem recall
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room…
Why was fMRI Hardware System - AudioSystem recalled?
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
HPS-2015-1.0-XXX HPS-2016-1.0-XXX
- Product
- fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room…
- Recalling firm
- NordicNeuroLab AS
- Quantity
- 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
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)