| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01016-1 |
| Product Name/Description |
Canon CXDI-70C Wireless and CXDI-80C Wireless (Computed Radiographic System)
Multiple serial numbers affected
ARTG Number: 176946 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
11/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for screws holding the back plate of the devices to come loose if the devices are exposed to axial rotation or repeatedly subjected to "external forces". |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Canon is providing work around instructions for the issue and will be replacing the loose screws in the base cover to correct the problem. |
| Contact Information |
02 9898 2444 - Shimadzu National Service |