FDA-Device2026-07-01Class IIPROCESSING DEFECT
IPG Medical Thuvera Laser Console software anomaly causes false error code display
What this means
A software issue in the Thuvera Laser Console (Software Version 2.2) causes the device to display a false error code 5018. This anomaly may lead clinicians to misinterpret the device status during operation.
- Contact IPG Medical Corporation if you operate an affected serial number unit
- Do not discard the device; await further instructions from the manufacturer
- Verify your device serial number against the affected list
The agency's original wording
Hazard
Software anomaly that causes a false display of error code 5018.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of MA.
Affected count
198 units
Manufactured in
225 Cedar Hill St, N/A, Marlborough, MA, United States
Products
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2554-2026Want us to check the next one for you?
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