| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00656-1 |
| Product Name/Description |
VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads
All units manufactured until December 2016
Light Head Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962, ARD568821913, ARD568821960 and ARD568822960
ARTG Number: 162037 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Getinge has identified that a screw is missing from the racket of the cupola on some devices in production. It is not yet confirmed whether the screw was missed during manufacture or had loosened over the life of the device.
As a consequence the light head shaft could break and the cupola could detach itself when manipulated and be held only by its cables. It appears such event is more likely to happen mainly during maintenance, cleaning and surgery preparation. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge are advising they will contact affected sites to plan for update of devices.
In the interim, users should verify whether the cupola has mechanical play by following the guidance provided in the Customer Letter. If no play in the cupola is detected the device may continue to be used. If play is detected, users should cease use of the device and contact Getinge immediately.
This action has been closed out on 26/07/2019 |
| Contact Information |
1800 438 464 - Getinge Customer Service |