Z-2554-2026Class II

Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser

Name: Z-2554-2026 Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser
Creator: IPG Medical Corporation
Published: 2026-05-05
License: https://open.fda.gov/license/

IPG Medical Corporation / initiated 2026-05-05 / Open, Classified / root cause: design

FDA source

IPG Medical Corporation began a recall of Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser on 2026-05-05. FDA classified it as Class II and gives the reason as "Software anomaly that causes a false display of error code 5018". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2554-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-05
Posted: 2026-06-24
Recalling firm: IPG Medical Corporation
Product: Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Software anomaly that causes a false display of error code 5018.
Root cause tag: design
FDA root cause: Device Design
Action: An URGENT MEDICAL DEVICE RECALL notice dated 05/05/2026 was emailed to IPG Medical's consignee notifying them of this recall correction to address Error 5018 and Error 5007/5023 displayed on monitors with software version 2.2. The notification provides instructions to consignees to work around the error messages until a software upgrade is deployed at a later date. The notification instructs consignees that their staff may correct units onsite via software upgrade or units may be returned to IPG Medical for a factory correction when the update is available. A corrected IFU will be provided to all customers. Questions can be directed via phone to 774-633-5903 or [email protected].
Quantity in commerce: 198 units
Distribution: US Nationwide distribution in the state of MA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2554-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2554-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24

Product code GEX

K232568Class IIIPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation / cleared 2024-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)