| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00401-1 |
| Product Name/Description |
Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray system)
ARTG 158774 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Hologic has identified the following compliance issues:
1. The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate.
2. The total cumulative irradiation time display is not accurate.
Both issues are caused by computational error which truncates the fractions of seconds after each image and therefore the time to alarm and the time displayed are shorter by the sum of these fractions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hologic is providing their customers with a revised version of the software. End users are requested to update their systems in accordance with the instructions provided with the update. |
| Contact Information |
1800 264 073 - Hologic Australia |