Beaver-Visitec International, Inc. recalls BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

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).

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.

• FDA enforcement recordOfficial FDA database entry for Z-1008-2026
• FDA 510(k) clearance · K240615The device's official FDA premarket clearance record
• FDA device classification · HQFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.4390The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beaver-Visitec International, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.