FDA DeviceClass IINotable

FDA Recall: Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

Date: 2026-07-01
Brand: IPG Medical Corporation
Category: Medical Device
FDA Class: Class II

Description

Software anomaly that causes a false display of error code 5018.

Hazard

Software anomaly that causes a false display of error code 5018.

Remedy

198 units

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