| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01522-1 |
| Product Name/Description |
Fujifilm Access Point for FDR Go Flex – DR-ID 1200 AP KIT E
(Computed radiographic system)
ARTG number: 175809 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
24/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
It was identified that the current labelling of the FUJIFILM wireless access point is not in keeping with Australian legislative requirements for Regulatory Compliance Mark (RCM). The DR-ID 1200 AP KIT E is compliant with the RCM and should be labelled accordingly with the certification label. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A new sticker with the Regulatory Compliance Mark will be supplied for the access points for customers to apply to the device.
This action has been closed out on the 12/11/2018. |
| Contact Information |
1800 060 209 - Fujifilm Service Team |