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IPG Medical Corporation: Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

Medical DevicesSource: FDA (device) · Date: 2026-07-01

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
IPG Medical Corporation
Product
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Reason / hazard
Software anomaly that causes a false display of error code 5018.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of MA.
Recall initiated
2026-05-05
Code info
Model No. MD2300F-001507; UDI-DI 00810071230226; Serial No. MDUF250342, MDUF250400, MDUF250429, MDUF250060, MDUF250061, MDUF250067, MDUF250068, MDUF250069, MDUF250071, MDUF250076, MDUF250083, MDUF250086, MDUF250091, MDUF250092, MDUF250104, MDUF250131, MDUF250133, MDUF250134, MDUF250159, MDUF250160, MDUF250199, MDUF250200, MDUF250202, MDUF250203, MDUF250204, MDUF250205, MDUF250240, MDUF250241, MDUF250242, MDUF250278, MDUF250297, MDUF250299, MDUF250312, MDUF250314, MDUF250325, MDUF250340, MDUF250341, MDUF250351, MDUF250352, MDUF250355, MDUF250367, MDUF250368, MDUF250370, MDUF250380, MDUF250384, MDUF250385, MDUF250395, MDUF250399, MDUF250409, MDUF250410, MDUF250427, MDUF250430, MDUF250431, MDUF250433, MDUF260009, MDUF260010, MDUF260011, MDUF260017, MDUF260019, MDUF260023, MDUF260024, MDUF260025, MDUF260026, MDUF260027, MDUF260032, MDUF260043, MDUF260067, MDUF260068, MDUF260070, MDUF260072, MDUF260077, MDUF260079, MDUF260094, MDUF260095, MDUF260096, MDUF260097, MDUF260098, MDUF260099, MDUF260100, MDUF260101, MDUF260103, MDUF260104, MDUF260105, MDUF260106, MDUF260107, MDUF260108, MDUF260109, MDUF260112, MDUF260115, MDUF250014, MDUF250015, MDUF250016, MDUF250050, MDUF250051, MDUF250052, MDUF250053, MDUF250054, MDUF250055, MDUF250056, MDUF250057, MDUF250058, MDUF250059, MDUF250062, MDUF250063, MDUF250064, MDUF250065, MDUF250066, MDUF250070, MDUF250072, MDUF250073, MDUF250074, MDUF250075, MDUF250084, MDUF250085, MDUF250088, MDUF250089, MDUF250090, MDUF250093, MDUF250102, MDUF250103, MDUF250105, MDUF250132, MDUF250145, MDUF250158, MDUF250161, MDUF250162, MDUF250198, MDUF250201, MDUF250206, MDUF250207, MDUF250220, MDUF250237, MDUF250238, MDUF250239, MDUF250243, MDUF250245, MDUF250279, MDUF250280, MDUF250295, MDUF250296, MDUF250298, MDUF250310, MDUF250311, MDUF250313, MDUF250323, MDUF250344, MDUF250348, MDUF250349, MDUF250350, MDUF250353, MDUF250357, MDUF250364, MDUF250365, MDUF250369, MDUF250371, MDUF250372, MDUF250378, MDUF250379, MDUF250381, MDUF250382, MDUF250383, MDUF250386, MDUF250393, MDUF250396, MDUF250397, MDUF250398, MDUF250407, MDUF250408, MDUF250411, MDUF250412, MDUF250428, MDUF250432, MDUF260016, MDUF260018, MDUF260020, MDUF260031, MDUF260041, MDUF260044, MDUF260069, MDUF260071, MDUF260078, MDUF260088, MDUF260089, MDUF260090, MDUF260091, MDUF260092, MDUF260093, MDUF250087, MDUF250208, MDUF250244, MDUF250324, MDUF250326, MDUF250354, MDUF250356, MDUF250394, MDUF260042, MDUF260045, MDUF260076; Software Version 2.2.
Product quantity
198 units
Voluntary mandated
Voluntary: Firm initiated
City
Marlborough
State
MA
Country
United States
Event id
99064
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