| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00120-1 |
| Product Name/Description |
Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems
Manufactured between August 2009 and July 2014
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 |
7/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Getinge, has received complaints concerning unintentional drifting of the cupola during surgery due to prematurely worn out brake screws. The observed movement is a slow rotation of the cupola around the axis, potentially shifting the light patch away from the wound.
Clinical evaluations concluded that there is a low risk of injury or other health consequences expected for the patient or the user. Only one (i.e. the heavier) cupola of a configuration is concerned by the malfunction, and the second cupola provides sufficient illumination of the surgical area if the issue occurs during surgery. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge is advising users that a service technician will be correcting all affected units.
This action has been closed out on 14/06/2019 |
| Contact Information |
1800 438 464 - Getinge Customer Service Support |