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 |
|
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 |