Class II

Medical Device Recall: (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.

LUMENIS, LTD. · January 23, 2025

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

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

States Affected

PA

Quantity Affected

3 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1290-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.