| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01394-1 |
| Product Name/Description |
MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System
(used with ONDAL Acrobat 2000 Spring Arms manufactured between Jan 2004 - Dec 2006)
Multiple Part Numbers
ARTG Number: 162037
(Getinge Australia Pty Ltd - Light, surgical) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
It has been concluded that there is a low failure rate that only can present itself on the devices of types and production identified in this letter. The issue relates to a crack in the metal of the spring arms that has the potential develop into a break. This potential for malfunction is caused by fissures near the weld seam at the front pivot of the spring arm. The design of the spring arm was improved in 2006. The devices are over ten years old and even so the vast majority have not failed. There have been related complaints, however to date no events involving injury have been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Getinge is advising users that all potentially affected spring arms will be replaced with new spring arms.
This action has been closed out on the 22/11/2018. |
| Contact Information |
1800 438 464 - Customer Service |