FDA-Device2026-01-07Class II
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Beaver-Visitec International, Inc.
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).
Sold states
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Affected count
5 units
Manufactured in
500 Totten Pond Rd, N/A, Waltham, MA, United States
Products
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2026Don't want to check this manually?
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