DIGORA Optime, DIGORA Optime UV (2020-01-04)
- Starting date:
- January 4, 2020
- Posting date:
- January 6, 2020
- 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-72013
Last updated: 2020-01-07
Affected Products
DIGORA Optime, DIGORA Optime UV
Reason
Following customer complaints, Palodex identified an issue with power supply units supplied with our imaging plate systems in 2012-2013. Slow degradation of plastic insulation in the power supply unit DC plug's insulation may result in short-circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the power supply unit to fail. No fire or flames have been reported, nor harm to patients or users. We confirmed devices were distributed in Canada on December 10, 2019.
Affected products
DIGORA Optime, DIGORA Optime UV
Lot or serial number
More than 10 codes, contact manufacturer.
Model or catalog number
DXR 50
Companies
- Manufacturer
-
Soredex Palodex Group OY
Nahkelantie 160
Tuusula
04300
FINLAND