WhichRecall
Class IIReported 2026-01-07

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Recalled by Beaver-Visitec International, Inc.

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

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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).

Recall Number
Z-1008-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-05
Reported
2026-01-07
Distribution
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Code Info
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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