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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01030-1
Product Name/Description All Welch Allyn KleenSpec Corded Illumination Systems
(used in conjunction with the KleenSpec Disposable Vaginal Specula)

Model Numbers: 78810, 78812, 78814 and 78816

Lot Numbers: All

ARTG Number: 101442
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/10/2015
Responsible Entity Welch Allyn Australia Pty Limited
Reason/Issue Welch Allyn has been made aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord. This may result in a shattered lamp and a potential electric shock hazard. Commonly available AC line power cords do not have an integrated wall transformer and therefore, the electrical current from the outlet is fully transferred into the device. There have been no associated injuries, but the misconnection can be reproduced. For example, the illuminator cord connector may fit into AC power cords from common consumer equipment, such as laptops, and other medical devices that have similar power cord connector.
Recall Action Recall for Product Correction
Recall Action Instructions Welch Allyn is providing users with additional labelling to place on the cords to remind users to only connect the Illuminator with the corresponding corded wall transformer. This action has been closed-out on 22/08/2016.
Contact Information 02 9638 3000 - Welch Allyn Technical Support