BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
FDA Recall #Z-1008-2026 — Class II — December 5, 2025
Product Description
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
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).
Recalling Firm
Beaver-Visitec International, Inc. — Waltham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5 units
Distribution
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Code Information
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated