Home / Recalls / Medical Devices
Beaver-Visitec International, Inc. recalls BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Recalled January 7, 2026 · FDA recall Z-1008-2026 · Beaver-Visitec International
Hazard
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). · FDA Class II
Units
5 units
Sold at
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Description
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).
Product
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Manufacturer(s)
Beaver-Visitec International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →