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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00050-1
Product Name/Description PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling Suspension

Units manufactured between March 2012 and July 2014

ARTG Number: 162037
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/01/2015
Responsible Entity Maquet Australia Pty Ltd
Reason/Issue Maquet received complaints of grinding on double (2 arms) or triple suspensions (3 arms), with paint possibly chipping from the junction between the 2 arms.
Paint chips or particles can fall down from the suspended lights. This may happen during surgical procedures, in which case, paint chips may fall inside the surgical field of a patient.
Recall Action Recall for Product Correction
Recall Action Instructions A Maquet technical specialist will arrange to inspect all potentially affected devices. Where grinding arms are detected a replacement of the suspension will be provided. This action has been closed-out on 05/09/2016.
Contact Information 1800 605 824 - Maquet Customer Service