Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36667 |
| Brand Name: | Lutronic - CLARITY II & CLARITY II LPA |
| Model: | LARITY II & CLARITY II LPA |
| Affected: | Serial number - C3025C065 |
| Software version: | |
| Recalling Organisation: | Ebos Medical Devices NZ limited 108 Wright Road Addington Christchurch 8024 |
| Contact Information: | |
| Manufacturer: | Lutronic Corporation |
| Issue: | The manufacturer has identified a potential safety-related issue may occur when operating the CLARITY II ICD system under high-fluence conditions (= 90-100 J/cm2, 1064nm) with cryogen cooling. Under these specific operating conditions, spark or loud noise (pop sound) may be observed during treatment and may increase the likelihood of localized minor burn/blister on the skin. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/3/2026 |
