Ipg Medical Corporation: Powered Laser Surgical Instrument

Recall Summary IPG Medical Corporation is recalling Thuvera Laser Console systems running Software Version 2.2 due to a software issue that displays a false error code 5018. The affected devices were distributed nationwide across all U.S. states and the District of Columbia. This is a Class II recall affecting powered laser surgical instruments used in medical procedures.

Recalling firm
IPG Medical Corporation
Product
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Reason
Software anomaly that causes a false display of error code 5018.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-05-05
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution in the state of MA.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b02f78a6-730c-4614-9805-4d6f3089869c