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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Lumenis Pulse 120H Laser Systems Recalled for Overheating and Power Failure

Agency Publication Date: March 5, 2025
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Summary

LUMENIS, LTD. is recalling 3 devices of the Lumenis Pulse 120H Laser System family because a hardware defect can cause internal components to overheat. This overheating occurs when the laser is turned on, damaging power resistors and causing the system to fail and not power up. No incidents or injuries have been reported, but the failure renders the device unusable for medical procedures. Owners should stop using the affected units and contact the manufacturer or their authorized distributor for a repair.

Risk

Internal components on the AC controller can overheat and sustain damage during the system's power-on sequence. This leads to a complete power failure, which may cause surgical delays or the inability to perform planned laser procedures.

What You Should Do

  1. This recall affects three specific Lumenis Pulse 120H Laser Systems using software version 2.4.1.0: the 30 amp model (REF GA-2009996, Serial 1791), the Moses 2.0 model (REF GA-0006802, Serial 1803), and the GA-0008700 model (Serial 1818).
  2. Stop using the recalled laser system immediately and remove it from active clinical service.
  3. Contact LUMENIS, LTD. or your authorized medical distributor to arrange for a return, replacement, or corrective repair of the laser system.
  4. For additional questions or to report an issue, call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Lumenis Pulse 120H 30 amp Laser System
Variants: Software version 2.4.1.0
Model / REF:
GA 2009996
Serial Numbers:
1791
UDI:
07290109145518

Recall #: Z-1290-2025

Product: Lumenis Pulse 120H, Moses 2.0 (DOM) Laser System
Variants: Software version 2.4.1.0
Model / REF:
GA0006802
Serial Numbers:
1803
UDI:
07290109145525

Recall #: Z-1290-2025

Product: Lumenis Pulse 120H Laser System
Variants: Software version 2.4.1.0
Model / REF:
GA-0008700
Serial Numbers:
1818
UDI:
07290109145464

Recall #: Z-1290-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96197
Status: Active
Manufacturer: LUMENIS, LTD.
Sold By: Authorized medical distributors
Manufactured In: Israel
Units Affected: 3 devices
Distributed To: Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.