Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21545 |
| Brand Name: | Angiodynamics Accu2i pMTA Applicator- Hyperthermia system applicator |
| Model: | 900-600; 900-601; 900-602 |
| Affected: | Various Lot numbers |
| Software version: | |
| Recalling Organisation: | Getz Healthcare Limited Level 17 120 Albert Street Auckland |
| Contact Information: | 0800 733 333 |
| Manufacturer: | AngioDynamics Inc (US) |
| Issue: | Manufacturer is recalling the Accu2i pMTA hyeprthermia system applicator as a potential failure mode has been identified of the tubing coolant line developing a leak within the applicator system which causes a "High Reflected Power" fault condition that makes the applicator inoperable to deliver microwave energy. Hazard 1: Applicator will not deliver power due to High Reflected Power fault condition. Hazard 2: Applicator's cooling line leaks cooling fluid within the applicator shaft. While the specific failure mode of the applicator not delivering the desired microwave energy would not result in any direct harm, the inserted applicator would need to be removed. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/6/2017 |
