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.
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).
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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The BVI Leos Laser and Endoscopy System is used in medical settings for minimally invasive procedures. Healthcare providers purchase this equipment to enhance patient safety and treatment efficacy.
The lack of ferrites on the USB cable can cause electrical interference, which may lead to device failure during use, posing a safety risk to patients.
This recall is not part of a broader industry pattern.
The recall affects a very limited number of units, but it requires immediate action to ensure patient safety and compliance with medical standards.
Serial numbers can typically be found on the back or bottom of the device and in the product documentation.
Expect a refund or replacement processing timeline of approximately 4-6 weeks after contacting the manufacturer.
Keep copies of all correspondence with the manufacturer, including emails and phone call notes.
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.
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