| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00089-2 |
| Product Name/Description |
FCR Go 2 (FCR-MB201) X-Ray System (Digital general purpose mobile diagnostic x-ray system)
ARTG 156199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Fujifilm Australia has been advised that in rare cases, if the exposure conditions (kV and mAs values) are changed manually on the control panel and the collimator lamp is turned on while concurrently pressing the electromagnetic break release switch on the collimator handle, the exposure settings are automatically reset to the values initially entered from the console. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised to reconfirm displayed values before performing exposure. A software update will be provided to customers to correct the issue. |
| Contact Information |
02 9466 2600 - Fujifilm |