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I-Portal Neuro Otologic Test Center (NOTC)(2015-04-28)
- Starting date:
- April 28, 2015
- Posting date:
- August 24, 2015
- 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-54758
Affected Products
A. I-Portal Neuro Otologic Test Center (NOTC)
Reason
Neuro Kinetics Inc. (NKI) has issued a voluntary device field correction related to a spontaneous unexpected chair rotation on one unit in the field. The unexpected chair rotation may happen upon unit start up. If the end user ignores software error message and continues with pressing "seating" or "testing" buttons. The error message is displayed before any involvement of a patient.
Affected products
A. I-Portal Neuro Otologic Test Center (NOTC)
Lot or serial number
SN#900152
SN#900164
Model or catalog number
I-PORTAL NOTC-P
I-PORTAL NOTC-S
Companies
- Manufacturer
-
Aim Instrumentation ltd
5232 IRMIN STREET
Burnaby
V5J 1Y7
CANADA