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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00347-1
Product Name/Description H LED and PowerLED Ambient Light Modules (Surgical light)

Model numbers: PWD700 and H LED 700

All lots manufactured from December 2006 to December 2012

ARTG Number: 162037
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/03/2014
Responsible Entity Maquet Australia Pty Ltd
Reason/Issue There is a potential risk of failure concerning the fixation of the Ambient Light Module. It has been observed by some of the customers that one or several fixing tabs were broken, which led the module to detach, remaining attached by its wires only. The occurrence rate observed is lower than 1% and is mainly seen in the early use of the devices.
Recall Action Recall for Product Correction
Recall Action Instructions All customers are asked to check if the ambient light module is correctly fixed. The procedure for this is provided with the customer letter. If any issues are detected by the customer, precautions should be taken in order to avoid the component falling and a Maquet representative should be contacted immediately in order to replace the broken ambient light module with a new one.
Contact Information 07 3339 3936 - Maquet Australia Pty Ltd