BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
- Recall Initiated
- December 5, 2025
- Posted
- December 31, 2025
- Recall Number
- Z-1008-2026
- Quantity
- 5 units
- Firm Location
- Waltham, MA
Reason for Recall
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).
Distribution
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Lot / Code Info
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Root Cause
Process control
Action Taken
Beaver-Visitec International (BVI) notified consignees via emailed letter on 12/05/2025. Consignees were informed that the affected units can still be used. A BVI service technician will contact each consignee to schedule a visit. During this visit, the missing ferrites will be installed to restore the equipment to its fully compliant and validated configuration. BVI aims to complete the correction by December 31st, 2025.