| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00727-1 |
| Product Name/Description |
Alcon LuxOR LX3 Microscope Floor Stand
(used with LuxOR LX3 and Q-VUE LX3 Ophthalmic Microscopes 175mm and 200mm)
Catalogue Number: 8065752560
ARTG Number: 210550 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Alcon has observed that multiple shipments or forceful impact to a caster on a LuxOR LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base. During an in-facility transfer, should a caster break or detach from the base while the microscope arm is not in the most inward locked position, the unit may tip if the microscope arm is extended over the location of the broken caster. This may lead to the potential for physical injury from the microscope tipping or falling.
To date, two incidents of physical injury have been reported overseas in conjunction with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alcon will contact users to schedule an appointment to inspect and retrofit LuxOR LX3 units with new bases and/or an updated caster configuration. In the interim, users are advised to ensure the articulating microscope arm is placed in a stowed and locked position over the microscope base and protect the casters from forceful impact. (Refer to recall notification for further details). Users are to contact their Alcon technical representative if they need to transport their unit to an off-site location or have immediate concerns about their unit.
This action has been closed out on the 26/09/2018. |
| Contact Information |
02 9452 9270 - Alcon Australia |