Health product recall

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