Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36769 |
| Brand Name: | Alphenix (all models) |
| Model: | Angiography system (INFX-8000C; INFX-8000V) |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Canon Medical Systems ANZ Pty Limited Akoranga Business Park 28 The Warehouse Way NorthCote AUCKLAND 0627 |
| Contact Information: | |
| Manufacturer: | Canon Medical Systems Corporation |
| Issue: | The manufacturer has identified that an internal error may occur when CAAS Clinical Functions are used during an examination, potentially causing a system lockup and loss of essential functions such as fluoroscopy and digital acquisition. Although a partial reset is recommended, the system may fail to restart due to temporary memory or storage read errors, leading to procedure interruptions or treatment delays that require a system restart. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/5/2026 |
