Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BVI Leos Laser and Endoscopy System. Model Number: OME6000U. Recalled by Beaver-Visitec International, Inc. Due to Manufacturing deviation in which the ferrites specified for...

Date: December 5, 2025
Company: Beaver-Visitec International, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Beaver-Visitec International, Inc. directly.

Affected Products

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

Quantity: 5 units

Why Was This Recalled?

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).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Beaver-Visitec International, Inc.

Beaver-Visitec International, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report