KT-DTM LAMP (2016-04-22)

Starting date:

April 22, 2016

Posting date:

May 16, 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-58378

• Reason
• Affected products

Affected products

1. KT-DTM LAMP

Reason

This information is initiated as a result of an investigation following the development of a new KT-D design in which the power density of the new design did not yield the same results made by two different testing facilities and with controlled and transferred methods. A detailed investigation has confirmed that there were issues related to the power density method, its transfer and its validation. It is possible that the power density of the KT-D lamp may have a higher value than the value currently approved in production established at 55.6 to 71.6 mw/cm2

Affected products