Medical Device Recall: BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Beaver-Visitec International, Inc. · December 5, 2025
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).
Distribution
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
States Affected
NATIONWIDE
Quantity Affected
5 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1008-2026
Status: ongoing
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