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Beaver-Visitec International, Inc.: BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Medical DevicesSource: FDA (device) · Date: 2026-01-07

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Beaver-Visitec International, Inc.
Product
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Reason / 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).
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Recall initiated
2025-12-05
Code info
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Product quantity
5 units
Voluntary mandated
Voluntary: Firm initiated
City
Waltham
State
MA
Country
United States
Event id
98076
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