Reported Jun 13, 2018 · Terminated
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation…
NordicNeuroLab AS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NordicNeuroLab AS · Mollendalsveien 65c · Bergen, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- HPS-2015-1.0-XXX HPS-2016-1.0-XXX
- Amount recalled
- 64 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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