FDAFDA · Alimentos y medicamentos·N.º oficial Z-2554-2026
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Publicado el 1 de julio de 2026 · Inicio del retiro: 5 de mayo de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Software anomaly that causes a false display of error code 5018.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- IPG Medical Corporation
- Distribuidor
- US Nationwide distribution in the state of MA.
- Lote
- 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.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.