Lumenis Pulse Laser System (Lumenis) – charger overheating (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel
Lot Codes / Batch Numbers
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.
Products Sold
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.
LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel is recalling (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM) due to The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recall was initiated via letter dated and issued on 1/23/2025 via FEDEX in the U.S. and via mail, courier, or hand delivery OUS. The letter explained the issue and the scenarios as to when the laser system would not power on. The consignee is instructed to immediately discontinue use and segregate the device, post this information in a visible location near the affected product to ensure the information is readily accessible to all handlers and users of the device, share the notice with any health care professional within your organization and with any organization where the affected product may have been transferred, and if the device has been further distributed, notify the customer to ensure this product removal is carried out to the end-user level. A Reply Verification Tracking Form was enclosed for completion and return. Once the firm receives the completed form, the consignee will be contacted within 2 business days and provided an RGA number for product return.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PA
Page updated: Jan 10, 2026