Z-1290-2025Class II

(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF...

Name: Z-1290-2025 (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF...
Creator: Lumenis, Ltd.
Published: 2025-01-23
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2025-01-23 / Open, Classified

FDA source

LUMENIS, LTD. began a recall of (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... on 2025-01-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1290-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-23
Posted: 2025-03-05
Recalling firm: Lumenis Ltd
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.
Product code: GEX Powered Laser Surgical Instrument
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 3 devices
Distribution: Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1290-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1290-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-05

Product code GEX

K170121Class IILumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd. / cleared 2017-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)