Health product recall

nordicBrainEx (2018-07-05)

Starting date:
July 5, 2018
Posting date:
October 26, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68066

Affected products

nordicBrainEx 

Reason

The design of the power supply contains ferrous/magnetic material. The precautionary measures not being followed by users is the main reason NNL (NordicNeuroLab) as has decided to recall the device. If user (in this case; operator, technical staff or installation personal) moves the LPS too close to the magnet one will feel an increased pull towards magnet.

Affected products

nordicBrainEx 

Lot or serial number

All lots.

Model or catalog number

V 2.3

Companies
Manufacturer
NORDICNEUROLAB AS
MOLLENDALSVEIEN 65C
BERGEN
5009
NORWAY