| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00717-1 |
| Product Name/Description |
Fluoroscopic Sonialvision G4
Serial Number: MP0002AD7001
Part Number: 566/10000/42
ARTG 141010
(Shimadzu Medical Systems Oceania Pty Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
Shimadzu Medical found that certain software versions of their X-ray TV system SONIALVISION G4 may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode.
Even when this event occurs, it is possible to solve this problem by turning off the power of the system once and then pressing the reset switch on the digital radiography unit's control cabinet.
However, there may be a possibility of delay or cancellation of the inspection because it is different from normal operation. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
· When switching from the fluoroscopy mode to the radiography mode, if a phenomenon occurs in which the image is not displayed, turn off the power of the system once and press the reset switch on the image collection cabinet. Then restart the system.
· Contact their local Shimadzu representative or contact Shimadzu National Technical Support as an authorised representative or technician will investigate potential affected products and will upgrade to the corrected software. |
| Contact Information |
1800 819422 - Shimadzu service number/recall@shimadzu.com.au |