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

• 
  Reason
• 
  Affected products

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