Recall Z-1008-2026 ยท HQF Laser, Ophthalmic
Beaver-Visitec International, Inc.
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
| Date | Dec 31, 2025 (initiated Dec 5, 2025) |
| Status | Open, Classified |
| Reason | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable). |
| Root cause | Process control |
| Action | Beaver-Visitec International (BVI) notified consignees via emailed letter on 12/05/2025. Consignees were informed that the affected units can still be used. A BVI service technician will contact each consignee to schedule a visit. During this visit, the missing ferrites will be installed to restore the equipment to its fully compliant and validated configuration. BVI aims to complete the correction by December 31st, 2025. |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the states of FL, MI, OK, TX, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K240615 | Leos Laser and Endoscopy System Beaver-Visitec International, Inc., Apr 3, 2025 |