FDA recall Z-2554-2026
IPG Medical Corporation · Class II · device
Product
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Reason for recall
Software anomaly that causes a false display of error code 5018.
Distribution
US Nationwide distribution in the state of MA.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-05-05
- Report date
- 2026-07-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Marlborough, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2554-2026