Beaver-Visitec International, Inc. — BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
⚠️ 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).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 5, 2025
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
What's affected?
- Product
- BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
- Lot code
- Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Additional details
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5 units.
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