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LUMENIS, LTD. recalls (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, La
Recalled March 12, 2025 · FDA recall Z-1290-2025 · LUMENIS
Hazard
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. · FDA Class II
Units
3 devices
Sold at
Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
Description
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
(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.
Manufacturer(s)
LUMENIS, LTD.
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →