(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Las

FDA device recall Z-1290-2025 · posted 2025-03-05 · Open, Classified

Recall details

Recalling firm

LUMENIS, LTD.

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.

Action taken

The recall was initiated via letter dated and issued on 1/23/2025 via FEDEX in the U.S. and via mail, courier, or hand delivery OUS. The letter explained the issue and the scenarios as to when the laser system would not power on. The consignee is instructed to immediately discontinue use and segregate the device, post this information in a visible location near the affected product to ensure the information is readily accessible to all handlers and users of the device, share the notice with any health care professional within your organization and with any organization where the affected product may have been transferred, and if the device has been further distributed, notify the customer to ensure this product removal is carried out to the end-user level. A Reply Verification Tracking Form was enclosed for completion and return. Once the firm receives the completed form, the consignee will be contacted within 2 business days and provided an RGA number for product return.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEX

Quantity affected

3 devices

Distribution

Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.

Date initiated

2025-01-23

Date posted

2025-03-05

Location

Ilit, Israel

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