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Recall Observatory FDA recall evidence

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.

Z-1290-2025

January 23, 2025

Class II

Product summary

Firm
LUMENIS, LTD.
Event
Event 96197
Status
Ongoing
Classification
Class II
Quantity
3 devices
Official record key
device-enforcement:Z-1290-2025

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.