LUMENIS, LTD.: Device Recall
Recall #Z-1290-2025 · 01/23/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1290-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- LUMENIS, LTD.
- Status
- Ongoing
- Date Initiated
- 01/23/2025
- Location
- Yokne'Am Ilit, Israel
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 devices
Reason for Recall
The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.
Product Description
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
Distribution Pattern
Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
Other Recalls by LUMENIS, LTD.
- Class II: Risk 07/22/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.