Z-2103-2018 Class II Terminated
FDA device recall Z-2103-2018 was initiated by NordicNeuroLab AS on October 28, 2017 and is designated Class II. Reason for recall: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones. The recall status is terminated (terminated March 31, 2021). Affected quantity: 64 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- October 28, 2017
- Termination Date
- March 31, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 units
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.
Distribution Pattern
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
Code Information
HPS-2015-1.0-XXX HPS-2016-1.0-XXX