Z-1290-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2025
- Initiation Date
- January 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 devices
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.
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.
Distribution Pattern
Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
Code Information
Software version 2.4.1.0. (1) REF GA-2009996 - Serial number 1791, UDI-DI 07290109145518; (2) REF GA-0006802 - Serial number 1803, UDI-DI 07290109145525; and (3) REF-GA0008700 - Serial number 1818, UDI-DI 07290109145464.