Lumenis Pulse 120H 30 amp recalled over fire hazard

Recall date

January 23, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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…

Recall number

Z-1290-2025

FDA classification

Class II

Brand / firm

LUMENIS, LTD.

Sold / distributed

Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

(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.