Data Foundry

Medical device recalls 2025

(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2)… — Class II medical device recall Z-1290-2025

Ongoing recall by LUMENIS, LTD., reported 2025-03-12. The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alter

Recall numberZ-1290-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmLUMENIS, LTD., Yokne'Am Ilit, Israel
Recall initiated2025-01-23
Classified2025-03-05
Reported by FDA2025-03-12
Countries outside the USES, MX
Quantity3 devices
Reason classesdevice malfunction
UPC / GTIN / UDI-DI07290109145464, 07290109145518, 07290109145525
Serial numbers1791, 1803, 1818
Model numbers2009996, GA-0006802, GA-0008700, GA-2009996, GA0006802, GA0008700

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1290-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.