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Open, Classified

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

FDA Recall Z-1008-2026 · Posted 2025-12-31

Recalling FirmBeaver-Visitec International, Inc.
Recall StatusOpen, Classified
Product CodeHQF
Date Initiated2025-12-05
Product Quantity5 units

Reason for Recall

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).

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of FL, MI, OK, TX, WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 2025-04-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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