FDA Enforcement
Class II
Ongoing
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Recall: Z-1008-2026
·
Reported January 7, 2026
Enforcement
- Recall Number
- Z-1008-2026
- Event ID
- 98076
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Beaver-Visitec International, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- January 7, 2026
- Initiation Date
- December 5, 2025
- Classification Date
- December 31, 2025
- Address
- 500 Totten Pond Rd, N/A, Waltham, MA, 02451-1916, United States
Description
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).
Code Info
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Distribution
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Quantity
5 units