(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, LTD. · 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-o…
Open FDA's page for this record- Cfres ID
- 212293
- Product res number
- Z-1290-2025
- Event date initiated
- 2025-01-23
- Event date posted
- 2025-03-05
- Recall status
- Open, Classified
- Res event number
- 96197
- Product code
- GEX
- Firm FEI number
- 3004135191
- Recalling firm
- LUMENIS, LTD.
- Address 1
- Yokneam Ind. Park 6 Ha-Kidma Yokne'Am
- City
- Ilit
- Country
- Israel
- Additional info contact
- Renee Archie 763-494-1133
- Root cause description
- Under Investigation by firm
- Product quantity
- 3 devices
- Distribution pattern
- Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
- Product description
(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.
- Code info
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.
- 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
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.
- K numbers
- K170121
- Harmonized identifiers (openFDA)
- Device name
- Powered Laser Surgical Instrument
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4810
- Device class
- 2
- K number
- K860273, K240520, K003781, K072779, K002899, K192483, K983020, K251230, K200659, K980547, K984486, K944346, K061470, K965124, K252753, K193426, K032220, K093691, K944558, K152220, K944437, K944632, K062336, K933525, K014057, K934008, K914455, K023734, K260632, K904229, K944151, K022466, K942622, K030805, K952598, K041095, K083918, K933322, K012806, K984517 +2,852 more
- Registration number
- 3017144492, 3038356864, 3016096097, 3017786046, 3043153468, 3007156625, 1000523114, 3002806603, 3012294783, 3007535734, 2031934, 3033126947, 3019252665, 2521877, 1226005, 3004497289, 3006985163, 3003610527, 3030979014, 9710340, 1424785, 3026400760, 3004111573, 3006786907, 3044175602, 2032092, 3016830208, 3010822033, 2027755, 3003288808, 3011050570, 3016170453, 3014577013, 3005282635, 3027605646, 3016413636, 3042261306, 3008085016, 3006580954, 3010363436 +453 more
- FEI number
- 3017144492, 3038356864, 3016096097, 3017786046, 3043153468, 1000623228, 1000523114, 3002806603, 3012294783, 3007535734, 3033126947, 3019252665, 2521877, 3004497289, 3006985163, 3003610527, 3030979014, 3026400760, 3003559308, 3004111573, 3006786907, 3044175602, 3016830208, 3010822033, 2027755, 3003288808, 3011050570, 3016170453, 3014577013, 3005282635, 3027605646, 3016413636, 3042261306, 3008085016, 3006580954, 3010363436, 3001362763, 2938889, 3042953831, 3004361445 +451 more