| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00111-1 |
| Product Name/Description |
Xray Screening table handle
S/N: MQC3548CA001
ARTG 141008
(Shimadzu Medical Systems Oceania Pty Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, analogue) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
It has been found that the Exposure Button on the handle of a control panel manufactured during a specific period may not be fully released from the ON state after releasing the button. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Shimadzu will replace the handle with an improved handle so that the Exposure Button is
released from the ON state without fail. Our Shimadzu service department will contact customers shortly to schedule this work.
Until such time that the work can take place, the following is recommended:
1. Perform daily inspections according to the Flexavision Operation Manual.
2. If any failures are observed, stop using the equipment and contact Shimadzu Medical Systems Service department.
This action has been closed out on 16/4/2024. |
| Contact Information |
1800 819422 - Shimadzu service number |