Neuro Omega system (2018-09-04)
- Starting date:
- September 4, 2018
- Posting date:
- October 5, 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-67880
Affected products
Neuro Omega system
Reason
In case Neuro Omega "Global stimulation return" connector of the EMG/ECOG Headbox is not properly connected, stimulation current may return through the Microelectrodes' contacts (Micro and Macro). Current can reach high charge density which may cause tissue harm.
Affected products
Neuro Omega system
Lot or serial number
Serial #: 173/06, 183/06,190
Model or catalog number
NEURO OMEGA
Companies
- Manufacturer
-
Alpha Omega Engineering LTD
Nazareth Industrial Park Building, Mount Precipice, P.O. Box 2268
Nazareth
1612102
ISRAEL