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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00120-1
Product Name/Description Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems

Manufactured between August 2009 and July 2014

Multiple Part Numbers

ARTG Number: 162037 (Getinge Australia Pty Ltd - Light, surgical)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/02/2018
Responsible Entity Getinge Australia Pty Ltd
Reason/Issue The manufacturer, Getinge, has received complaints concerning unintentional drifting of the cupola during surgery due to prematurely worn out brake screws. The observed movement is a slow rotation of the cupola around the axis, potentially shifting the light patch away from the wound.

Clinical evaluations concluded that there is a low risk of injury or other health consequences expected for the patient or the user. Only one (i.e. the heavier) cupola of a configuration is concerned by the malfunction, and the second cupola provides sufficient illumination of the surgical area if the issue occurs during surgery.
Recall Action Product Defect Correction
Recall Action Instructions Getinge is advising users that a service technician will be correcting all affected units.

This action has been closed out on 14/06/2019
Contact Information 1800 438 464 - Getinge Customer Service Support