Device product
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.
Z-2103-2018
Product summary
- Event
- Event 78848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 units
- Official record key
device-enforcement:Z-2103-2018
Official wording
Reason: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Code information: HPS-2015-1.0-XXX HPS-2016-1.0-XXX
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
Derived failure modes
-
Unknown
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.