Class II — Beaver-Visitec International, Inc.
| Recalling firm | Beaver-Visitec International, Inc. |
|---|---|
| Registered facility | Beaver-Visitec International, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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). |
| Product | BVI Leos Laser and Endoscopy System. Model Number: OME6000U. |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the states of FL, MI, OK, TX, WI. |
| Initiated | 2025-12-05 |
| Classified | 2025-12-31 |
| Recall number | Z-1008-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beaver-Visitec International, Inc. (Z-1008-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98076/
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