FDA
Food and Drug Administration · Recall Z-2554-2026 · May 5, 2026Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
IPG Medical Corporation
The hazard
Software anomaly that causes a false display of error code 5018. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Model No. MD2300F-001507Model UDI-DI 00810071230226Model Serial No. MDUF250342Model MDUF250400Model MDUF250429Model MDUF250060Model MDUF250061Model MDUF250067Model MDUF250068Model MDUF250069Model MDUF250071Model MDUF250076Model MDUF250083Model MDUF250086Model MDUF250091Model MDUF250092Model MDUF250104Model MDUF250131Model MDUF250133Model MDUF250134Model MDUF250159Model MDUF250160Model MDUF250199Model MDUF250200Model MDUF250202UPC 00810071230226Would you have heard about this one?
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