1500T14 Cardiac Ablation System - Generator (2014-03-11)

Starting date:

March 11, 2014

Posting date:

April 14, 2014

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-39031

• 
  Reason
• 
  Affected products

Recalled Products

1500T14 Cardiac Ablation System - Generator

Reason

A very small number of incidents have been reported for another model (1500T12) of IBI Therapy generator where the generator initiated the unintended delivery of RF energy when the user was making settings adjustments. The generator is designed to only initiate RF energy when the start/stop key is pressed. However, due to a potential for internal circuitry damage caused by electrostatic discharge, the generator controls may be adversely affected. Although no such incidents have been reported with the 1500T14 generator, it contains the same internal circuitry as the 1500t12 generator that is vulnerable to potential damage caused by electrostatic discharge. As a result, it is being included in this action.

Affected products