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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00045-1
Product Name/Description	MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD5688112962, ARD568821913 Serial Numbers (up to, for the above part numbers respectively): 50000, 500063, 500003, 500030, 500004, 50000, 500046, 500007, 500001 ARTG Number: 162037 (Getinge Australia Pty Ltd - Light, surgical)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	16/01/2018
Responsible Entity	Getinge Australia Pty Ltd
Reason/Issue	Getinge has received complaints indicating that the central handle holder detaches easily from the cupola during use. We determined that the root cause of this malfunction is excessive tightening of the screws during mounting of the handle holder, resulting in the rivets loosening and detaching from the central handle holder ring. During manipulation, the handle holder may completely detach from the light head, if all three rivets loosen simultaneously. In this case, although the handle remains in the user’s hand, small quantities of particles may be generated from the plastic holder ring.
Recall Action	Product Defect Correction
Recall Action Instructions	Getinge will be in contact with affected users to arrange for a service technician to replace existing central holder rings. This action has been closed out on the 29/11/2018.
Contact Information	1800 438 464 - Getinge Customer Service