Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
FDA device recall Z-2554-2026 · posted 2026-06-24 · Open, Classified
Recall details
- Recalling firm
- IPG Medical Corporation
- Reason for recall
- Software anomaly that causes a false display of error code 5018.
- Action taken
- 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 all customers. Questions can be directed via phone to 774-633-5903 or koconnell@ipgmedical.com.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- GEX
- Quantity affected
- 198 units
- Distribution
- US Nationwide distribution in the state of MA.
- Date initiated
- 2026-05-05
- Date posted
- 2026-06-24
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories (K232568) | Ipg Medical Corporation | 2024-03-21 |