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ARTIS DIALYSIS SYSTEM(2015-09-17)
- Starting date:
- September 17, 2015
- Posting date:
- October 8, 2015
- 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-55296
Affected Products
SYSTÈME DE DIALYSE ARTIS
Reason
There have been reports of a burning smell/smoke coming out from the upper ventilation grids of the Artis dialysis machine. The events have been associated with a limited number of power supply units manufactured with a specific batch of capacitor. The technical analysis identified that the issue was caused by a defective capacitor inside the power supply unit which has the potential to melt after approximatively 4 years of use.
Affected products
ARTIS DIALYSIS SYSTEM
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
112949
Companies
- Manufacturer
-
Gambro Dasco S.P.A.
Via Modenese 66
Medolla
ITALY