BVI Leos Laser and Endoscopy System. Model Number: OME6000U recallZ-1008-2026 · Beaver-Visitec International, Inc. · initiated Dec 5, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beaver-Visitec International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1008-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 5, 2025
- Posted by the FDA
- Dec 31, 2025
- Recalling firm
- Beaver-Visitec International, Inc.
- Quantity
- 5 units
- Product code
- HQF
- FDA submissions
- K240615
- Distribution
- US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Product description
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Code information (models, lots, serial numbers)
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BVI OME6001UBeaver-Visitec International, Inc. · Unit, cautery, thermal, battery-powered1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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