Product Wiki · Recalls · Health Canada — Medical Devices

1500T14 Cardiac Ablation System - Generator (2014-03-11) — recall 51504

Health Canada — Medical Devices · Canada · 2014-04-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
51504
Date of alert
2014-04-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/1500t14-cardiac-ablation-syste

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