Recall Z-2554-2026 ยท GEX Powered Laser Surgical Instrument
IPG Medical Corporation
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
| Date | Jun 24, 2026 (initiated May 5, 2026) |
| Status | Open, Classified |
| Reason | Software anomaly that causes a false display of error code 5018. |
| Root cause | Device Design |
| Action | An URGENT MEDICAL DEVICE RECALL notice dated 05/05/2026 was emailed to IPG Medical's consignee notifying them of this recall correction to address Error 5018 and Error 5007/5023 displayed on monitors with software version 2.2. The notification provides instructions to consignees to work around the error messages until a software upgrade is deployed at a later date. The notification instructs consignees that their staff may correct units onsite via software upgrade or units may be returned to IPG Medical for a factory correction when the update is available. A corrected IFU will be provided to |
| Quantity | 198 units |
| Distribution | US Nationwide distribution in the state of MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories Ipg Medical Corporation, Mar 21, 2024 |