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U.S. Department of Health and Human Services

Class 2 Device Recall Lumenis

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 Class 2 Device Recall Lumenissee related information
Date Initiated by FirmJanuary 23, 2025
Date PostedMarch 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1290-2025
Recall Event ID 96197
510(K)NumberK170121 
Product Classification Powered laser surgical instrument - Product Code GEX
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.
Code Information 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.
FEI Number 3004135191
Recalling Firm/
Manufacturer		 LUMENIS, LTD.
Yokneam Ind. Park
6, Ha-Kidma
Yokne'Am Ilit Israel
For Additional Information ContactRenee Archie
763-494-1133
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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.
Quantity in Commerce3 devices
DistributionDistribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEX
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