Recall Z-1290-2025 ยท GEX Powered Laser Surgical Instrument
LUMENIS, LTD.
(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.
| Date | Mar 5, 2025 (initiated Jan 23, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 pro |
| Quantity | 3 devices |
| Distribution | Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories Lumenis, Ltd., May 22, 2017 |