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Stimpod NMS450 Nerve Stimulator (2015-12-15)
- Starting date:
- December 15, 2015
- Posting date:
- June 30, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59100
Affected products
A. Stimpod NMS450 Nerve Stimulator
Reason
In isolated incidences (less than 0.003%) while using the device in NMBA monitoring mode, electrodes used may deteriorate to a level where current densities may be large enough to cause superficial burns on the skin of the patient.
Affected products
A. Stimpod NMS450 Nerve Stimulator
Lot or serial number
All lots
Model or catalog number
XT-41000-NA
XT-41001-NA
Companies
- Manufacturer
-
Xavant Technology (PTY) LTD.
Unit 102 Tannery Industrial Park, 309 Derdepoort Road
Silverton
0184
SOUTH AFRICA