| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00455-1 |
| Product Name/Description |
Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis
EDS Light Suspensions Item Numbers (Serial Numbers):
0682-001-566 (15K002818, 15K002498, 15K002518, 15K002508)
0682-400-142 (15L004128)
0682-400-148I (16C001798)
0682-001-567I (15L006528)
ARTG Number: 118878 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has become aware that there is a remote likelihood that the EDS Light Suspension, Central Axis may have an insufficiently assembled joint in the suspension. If the EDS Light Suspension, Central Axis falls, it could potentially cause serious injuries to health care providers and/or patients. To date, there have been no adverse events reported to Stryker for this issue worldwide. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Stryker Technician will contact users to organise a time to perform an inspection of the product. If a correction is required the central axis will be replaced. In the interim, if the product malfunctions, users are to immediately discontinue its use and contact Stryker immediately.
This action has been closed-out on 21/03/2018. |
| Contact Information |
02 9467 1175 - Stryker |