Recall Z-1290-2025— LUMENIS, LTD.

Name: FDA recall Z-1290-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-23

Class II · Ongoing

Class II FDA medical device recall by LUMENIS, LTD., initiated 2025-01-23. It names one FDA 510(k) clearance: K170121. 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: 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..

Recalling firm: LUMENIS, LTD.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-23
Firm location: Yokne'Am Ilit, Israel

510(k) clearances named in this recall

1 on FDA's record

K170121 — Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.·cleared 2017-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.