CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
Lumenis Pulse 120H 30 amp recalled
Lumenis is recalling Lumenis Pulse 120H 30 amp, distributed in Pennsylvania. The recall was initiated on 23 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1290-2025
- FDA event ID
- 96197
- Recalling firm
- Lumenis, Yokne'Am Ilit
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jan 2025
- FDA classified
- 5 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Jan 2025 | Recall initiated by company | |
| 5 Mar 2025 | Classified by FDA | +41 days |
| 12 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
(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.
Where it was distributed
Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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