FDA DevicesClass II
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Published: July 1, 2026Recall ID: Z-2554-2026Category: devicesCountry: US
Reason for Recall / Hazard
Software anomaly that causes a false display of error code 5018.
Product Description & Identification
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 99064 |
| Address 1 | 225 Cedar Hill St |
| Address 2 | N/A |
| Code info | Model No. MD2300F-001507; UDI-DI 00810071230226; Serial No. MDUF250342, MDUF250400, MDUF250429, MDUF250060, MDUF250061, MDUF250067, MDUF250068, MDUF250069, MDUF250071, MDUF250076, MDUF250083, MDUF250086, MDUF250091, MDUF250092, MDUF250104, MDUF250131, MDUF250133, MDUF250134, MDUF250159, MDUF250160, MDUF250199, MDUF250200, MDUF250202, MDUF250203, MDUF250204, MDUF250205, MDUF250240, MDUF250241, MDUF250242, MDUF250278, MDUF250297, MDUF250299, MDUF250312, MDUF250314, MDUF250325, MDUF250340, MDUF250341, MDUF250351, MDUF250352, MDUF250355, MDUF250367, MDUF250368, MDUF250370, MDUF250380, MDUF250384, MDUF250385, MDUF250395, MDUF250399, MDUF250409, MDUF250410, MDUF250427, MDUF250430, MDUF250431, MDUF250433, MDUF260009, MDUF260010, MDUF260011, MDUF260017, MDUF260019, MDUF260023, MDUF260024, MDUF260025, MDUF260026, MDUF260027, MDUF260032, MDUF260043, MDUF260067, MDUF260068, MDUF260070, MDUF260072, MDUF260077, MDUF260079, MDUF260094, MDUF260095, MDUF260096, MDUF260097, MDUF260098, MDUF260099, MDUF... [TRUNCATED] |
| Postal code | 01752-5900 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 198 units |
| Reason for recall | Software anomaly that causes a false display of error code 5018. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260505 |
| Initial firm notification | |
| Center classification date | 20260624 |
Overview
- Recalling FirmIPG Medical Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of MA.