| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00200-1 |
| Product Name/Description |
ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)
Lot Numbers: HA.2200.902 and HA.2237.902
Multiple Serial Numbers affected
Manufactured between 1 June - 26 November 2015.
ARTG Number: 168578 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
A manufacturing defect has been detected which could lead to the loosening of the rivets of the interface plate that connects the monitor and touch screen to the articulating arms on the trolley (VESA 75/ 100 adaptation with rotation). The riveting of the rotation may not have been carried out according to the manufacturer's specifications.
In rare cases, it can lead to a loosening of the connection plate and result in injuries to patients and/or users. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
KARL STORZ is advising customers that they can opt for their own engineers to replace the adaptor plates or nominate KARL STORZ to replace the affected component on site. |
| Contact Information |
02 9490 6700 - Karl Storz |