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QUANTUM SYSTEM (2015-11-18)
- Starting date:
- November 18, 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-56096
Affected Products
QUANTUM SYSTEM
Reason
During internal testing, it was identified that in Neuroworks with Quantum hardware, the incoming signal is displayed with reversed polarity.
Affected products
QUANTUM SYSTEM
Lot or serial number
- 013926030059
- 013926030060
- 013926030074
- 013926030075
Model or catalog number
- 013926
Companies
- Manufacturer
-
Natus Medical Incorporated DBA Excel-Tech Ltd (XLTEK),
2568 Bristol Circle,
Oakville,
L6H 5S1
Ontario
CANADA