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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00656-1
Product Name/Description VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads

All units manufactured until December 2016

Light Head Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962, ARD568821913, ARD568821960 and ARD568822960

ARTG Number: 162037
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 31/05/2018
Responsible Entity Getinge Australia Pty Ltd
Reason/Issue Getinge has identified that a screw is missing from the racket of the cupola on some devices in production. It is not yet confirmed whether the screw was missed during manufacture or had loosened over the life of the device.
As a consequence the light head shaft could break and the cupola could detach itself when manipulated and be held only by its cables. It appears such event is more likely to happen mainly during maintenance, cleaning and surgery preparation.
Recall Action Product Defect Correction
Recall Action Instructions Getinge are advising they will contact affected sites to plan for update of devices.
In the interim, users should verify whether the cupola has mechanical play by following the guidance provided in the Customer Letter. If no play in the cupola is detected the device may continue to be used. If play is detected, users should cease use of the device and contact Getinge immediately.

This action has been closed out on 26/07/2019
Contact Information 1800 438 464 - Getinge Customer Service