Lumenis Pulse 120H recallZ-1290-2025 · Lumenis, Ltd. · initiated Jan 23, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Lumenis, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1290-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 23, 2025
- Posted by the FDA
- Mar 5, 2025
- Recalling firm
- Lumenis, Ltd.
- Quantity
- 3 devices
- Product code
- GEX
- FDA submissions
- K170121
- Distribution
- Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
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.
Code information (models, lots, serial 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.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Lumenis Pulse 120H Lumenis Pulse Moses 2.0 (DOM)Lumenis Ltd. · Powered Laser Surgical Instrument1 recall161 reports
- Lumenis Pulse 120HLumenis Ltd. · Powered Laser Surgical Instrument1 recall34 reports
- Lumenis Pulse 120H Lumenis Pulse P120 30 AmpLumenis Ltd. · Powered Laser Surgical Instrument1 recall22 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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