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MEDICAL DEVICE RECALLMODERATE

Thuvera Laser Console

IPG Medical is recalling the Thuvera Laser Console due to a software anomaly that may cause a false error code 5018 display.

What to do

Contact IPG Medical Corporation to schedule a software update to resolve the anomaly.

Recalled
Listed
Updated
Recall No.
Z-2554-2026
Agency
FDA
Firm
IPG Medical Corporation
Recall ID
99064
Status
ONGOING

Recall at a glance

Quantity recalled
198 units

Why it was recalled

IPG Medical is recalling the Thuvera Laser Console, a portable thulium fiber laser, due to a software anomaly that may cause the device to incorrectly display error code 5018. This error can interrupt the intended use of the device during medical procedures.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
00810071230226

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Software Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-06-25 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification