FDA recall Z-2103-2018

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.

Reason for recall

Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

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

Key facts

Status

Terminated

Initiation date

2017-10-28

Report date

2018-06-13

Termination date

2021-03-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bergen, N/A, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2103-2018