Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22432
Brand Name:Lights - Ardon
Model:5214 MAQUET VOLISTA StanOP, TRIPOD and ACCESS Cupolas Surgical lights manufactured before July 2016.
Affected:
Software version:
Recalling Organisation:Getinge Australia Pty Ltd (NZ)
Unit D, Ground Floor, Building A, Millenium Centre
600 Great South Rd
Ellerslie
Auckland 1051
Contact Information:09 272 9039
Manufacturer:Maquet SA
Issue:The manufacturer has received complaints indicating that the central handle holder detaches easily from the cupola during use. It was determined that the 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.
Recall action type:Correction
Recall action:Product to be exchanged
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:12/1/2018
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