Lutronic - Clarity II & Clarity II Lpa
- Recalling firm
- Ebos Medical Devices NZ limited
- Product
- Lutronic - CLARITY II & CLARITY II LPA. [Device]. Model: LARITY II & CLARITY II LPA. Affected: Serial number - C3025C065
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-18
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/729c892e-d735-4423-951d-b9483566af3e