FDA DevicesClass II
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Published: January 7, 2026Recall ID: Z-1008-2026Category: devicesCountry: US
Reason for Recall / Hazard
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).
Product Description & Identification
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Additional Source Details
| Field | Value |
|---|---|
| City | Waltham |
| State | MA |
| Event id | 98076 |
| Address 1 | 500 Totten Pond Rd |
| Address 2 | N/A |
| Code info | Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010. |
| Postal code | 02451-1916 |
| Report date | 20260107 |
| Product type | Devices |
| Product quantity | 5 units |
| 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). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251205 |
| Initial firm notification | |
| Center classification date | 20251231 |
Overview
- Recalling FirmBeaver-Visitec International, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of FL, MI, OK, TX, WI.