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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: HPS-2015-1.0-XXX HPS-2016-1.0-XXX
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- NordicNeuroLab AS
- Reason for Recall:
- Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
HPS-2015-1.0-XXX HPS-2016-1.0-XXX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2103-2018
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