BVI Leos Laser and Endoscopy System. Model Number: OME6000U. recall (Beaver-Visitec International, Inc.)
Medical deviceClass IIOngoing
Summary: Beaver-Visitec International, Inc. is recalling BVI Leos Laser and Endoscopy System. Model Number: OME6000U.. Reason: 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 is being recalled
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Why
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).
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of FL, MI, OK, TX, WI. (states named: Florida, Michigan, Oklahoma, Texas, Wisconsin)
How to tell if yours is affected
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1008-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 5, 2025 |
| Reported | January 7, 2026 |
| Company | Beaver-Visitec International, Inc. |
| Company location | Waltham, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5 units |
More recalls from Beaver-Visitec International, Inc. · all medical device recalls · recalls from December 2025