| TGA Action ID |
RC-2026-RN-00763-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VERSA Accessory Cart
REF: 1000-0021
Serial Number(s): VC0147, VC0153
Associated System: VERSA Mini C-Arm System
REF: 1000-0020
Serial Number(s): 6A0146, 6A0152 |
| ARTG Number |
157136 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The manufacturer, Ziehm-Orthoscan, received a complaint which involved the separation of the monitor arm mounting structure from the VERSA Cart Tower at the tower top plate/ cart tower welded interface. The monitor arm mounting structure detached from the cart tower due to a weld that did not meet manufacturing specifications.
Unintended movement of the display support assembly may occur, potentially resulting in device damage or injury to individuals near the system. Injury to the user resulting from contact with the falling monitor or monitor arm assembly may include potential head, facial, musculoskeletal, contusion, or laceration injuries.
To date, the manufacturer has received one complaint related to this problem. No injuries or adverse health effects were reported. |
| Instructions for Customers/Users |
Customers are to:
- Exercise caution when positioning, moving, or operating the system and monitor assembly, avoid fully extending the display arm until the corrective action has been performed.
- If unintended movement, instability, loosening, or any other condition related to the problem described in this notification is observed, discontinue use of the affected system and contact Medical + Optical for further instructions.
Affected customers will be contacted by Medical + Optical to coordinate a site visit to inspect the device and install a new bracket. |
| Action Commencement Date |
2/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 225 065 - Medical + Optical Instruments |