Recall Z-2103-2018 ยท LNH System, Nuclear Magnetic Resonance Imaging
NordicNeuroLab AS
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.
| Date | Oct 28, 2017 |
| Status | Terminated |
| Reason | Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones. |
| Root cause | Device Design |
| Action | The firm notified the consignees by email on September 28, 2017. The units were to be returned. For further questions, please call 1 (855) 665-3674 option 1. |
| Quantity | 64 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080515 | FMRI HARDWARE SYSTEM Nordicneurolab, May 16, 2008 |