| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01371-1 |
| Product Name/Description |
Drystar DT 2 C Hardcopy Film 14" x 17"
Reference: EKMCU
Batch Numbers: 36650011 (exp 2018-06) and 69030031 (exp 2018-10)
ARTG Number: 119352 (AGFA HealthCare Australia - Photographic film, diagnostic imaging) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Agfa Healthcare is advising that due to an error in manufacturing, specific film boxes have unreadable RF-tags. If these boxes are used in printers, the printer will generate an error message, and it will not be possible to print images.
If users were able to use the affected film there is no problem with the image quality or the diagnostic properties. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Agfa Healthcare is advising users to use an alternative film if the issue occurs.
This action has been closed out on 17/10/2018 |
| Contact Information |
03 9756 4100 - AGFA Healthcare |