FDA recall Z-1290-2025

LUMENIS, LTD. · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-01-23
Report date
2025-03-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Yokne'Am Ilit, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1290-2025