FDA-Device2026-07-01Class IIPROCESSING DEFECT
IPG Medical Thuvera Laser Console software anomaly causes false error code display
OTHERNationwide distribution
IPG Medical Thuvera Laser Console recalled for false error display
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
Hazard
Software anomaly that causes a false display of error code 5018.
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-2554-2026Don't want to check this manually?
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