HIGH

Beaver-Visitec Recalls Laser and Endoscopy System Over Safety Hazard

Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.

Quick Facts at a Glance

Recall Date
December 5, 2025
Hazard Level
HIGH
Brand
Beaver-Visitec International
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beaver-Visitec International, Inc. or your healthcare provider for instructions. Notification method: E-Mail

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Product Details

The recalled product is the BVI Leos Laser and Endoscopy System, Model Number OME6000U. It affects five units with serial numbers 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, and 77UBV500010. The product was distributed nationwide in Florida, Michigan, Oklahoma, Texas, and Wisconsin.

The Hazard

The omission of ferrites on the USB communication cable results in non-conformance to design specifications. This deviation can lead to electrical hazards that may compromise the device's functionality.

Reported Incidents

No injuries or incidents have been reported as a direct result of this defect. However, the risk associated with the electrical failure is classified as high.

What to Do

Stop using the device immediately. Contact Beaver-Visitec International or your healthcare provider for further instructions. Follow the recall instructions provided via email.

Contact Information

For further assistance, contact Beaver-Visitec International at their official website or through the recall notification email.

Key Facts

  • Model Number: OME6000U
  • Five units recalled
  • Distributed in FL, MI, OK, TX, WI
  • High electrical hazard risk
  • Stop using immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICAL

Product Classification

Product TypeLaser and Endoscopy System
Sold At
Multiple Retailers

Product Details

Model Numbers
OME6000U
Affected States
ALL
Report Date
January 7, 2026
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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