Lumenis Pulse 120H Laser System Charger May Prevent Device Startup
Lumenis recalled three Pulse 120H laser systems due to a charger defect. The charger's initial current can damage AC controller power resistors, preventing the device from powering on.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is device malfunction rather than direct patient harm; the laser system fails to power on due to charger defect. Without reported adverse events and with the defect being functional rather than presenting immediate safety risk, this meets criteria for Moderate severity.
Plain-English summary
Lumenis, Ltd. has recalled three Lumenis Pulse 120H laser systems with software version 2.4.1.0 due to a charger defect. The affected models are REF GA-2009996 (serial 1791), REF GA-0006802 (serial 1803), and REF GA-0008700 (serial 1818).
The issue involves excessive initial current from the charger during the laser system's power-on sequence. This can cause overheating and damage to the power resistors on the Alternating Current (AC) controller, preventing the laser system from powering on.
The affected devices were distributed to Pennsylvania in the United States, as well as to Mexico and Spain. No distribution was made to government or military facilities.
Users with affected devices should contact Lumenis, Ltd. for instructions on addressing the charger defect.
The recalled product
- 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.
- Manufacturer
- LUMENIS, LTD.
- Category
- Medical Device — Laser System
- Hazard
- overheating
- component-damage
- device-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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.
Distribution
Distributed in 1 state:
- PA
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