| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01265-1 |
| Product Name/Description |
i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0
ARTG Number: 219343 (TBC) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
After upgrading the Cassini software to version 2.0.0, the Cassini patient database may have been
compromised, resulting in patient examination data being linked to the wrong patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Technical support representative will contact affected customers to inspect and, if necessary, to correct the issue. During the restoration process, the Cassini device will be locked and cannot be used. This is estimated to take 1 to 3 hours. Until the database integrity has been ensured, users are advised not to use patient examination data unless verified to be correctly associated with the patient.
A software patch is under development (version 2.0.1, expected mid-December) including making a back-up before updating and a database check before and after an update.
This action was undertaken prior to consultation with the Therapeutic Goods Administration. This action has been closed out on 29/01/2016. |
| Contact Information |
08 8357 8022 - IQ Medical |