| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01361-1 |
| Product Name/Description |
Zymed Holter Converter (Cardiology information system designed for the collection and management of electrocardiography data)
ARTG number: 171621 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential problem with the Zymed Holter Converter If more than one instance of the program was inappropriately started, the PDF image for patient could be generated incorrectly.
This recall action was undertaken prior to agreement of the recall strategy by the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Epiphany Healthcare (the manufacturer) installed a software patch to correct the software error. |
| Contact Information |
02 9466 2639 - Fujifilm Australia |