Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14588 |
| Brand Name: | Hologic Mini C-arm |
| Model: | InSight and InSight 2 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Pharmaco (NZ) Ltd Level 1 4 Fisher Crescent Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 804 079 |
| Manufacturer: | Hologic Inc |
| Issue: | Manufacturer 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 accuarate. 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. This non-compliance does not pose a health hazard, as the radiation exposure to a patient depends on power settings during the procedure. The system provides the user with accurate dose to the patient information by displaying Air Kerma and Cumulative Air Kerma. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/6/2013 |
