Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-01151-1 |
Product Name/Description |
YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)
Part Number: 1433.62A1; Serial number: 001-107
Part Number: 1433.62A0; All serial numbers
ARTG Number: 163023
|
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
14/11/2012 |
Responsible Entity |
|
Reason/Issue |
Maquet has identified a potential issue with the release lever of the screw tension mechanism, whereby it may be difficult to set or maintain the desired traction. This issue can occur during use with any patient population, however it is most likely to occur when setting higher tensions. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
A Maquet authorised Service Engineer is to arrange an appointment to assess the affected devices and to replace the release lever. Customers are advised to be aware that they may experience difficulty with the tension mechanism until the repair/replacement activity is performed. |
Contact Information |
07 3339 3936 - Maquet |