LUMENIS, LTD.: Medical Device Recall in 2025 - (Recall #: Z-1290-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 23, 2025

Date Posted: March 12, 2025

Recall Number: Z-1290-2025

Event ID: 96197

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.

Status: Ongoing

Product Quantity: 3 devices

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated