FDA Medical devices recall ·
(1) Lumenis Pulse 120H 30 amp recall
- Recall number
- Z-1290-2025
- Date
- (initiated January 23, 2025)
- Company / brand
- Lumenis, Ltd.
Yokneam Ind. Park, Yokne'Am Ilit, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1290-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.