FDADecember 5, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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).

What to do

FDA enforcement status: Ongoing

Brands named

beaver visitecbeaverbeaver visitec

UPCs

00886158037576

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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BVI Leos Laser and Endoscopy System. Model Number: OME6000U. — Recall Details · AllClear