Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21332 |
| Brand Name: | HS Hospital Service SpA Amica Dual Ablation System |
| Model: | HS-AGN-H-1.0 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | HS Hospital Service SpA |
| Issue: | A manufacturer's internal audit has discovered that a Power Supply Unit that was installed in the Generators above was not in compliance with the CE certification. Due to this, the CE certification has been withdrawn from specific Serial numbers only. The manufacturer has advised that electrical safety tests performed on these Generators have passed and the reports are valid, and see no potential risk for patients or users. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/4/2017 |
