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.
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.
Recall #: Z-1290-2025
Recall #: Z-1290-2025
Recall #: Z-1290-2025
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.
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
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