Beaver-Visitec BVI Leos Laser and Endoscopy System recalled for USB cable manufacturing defect
What this means
Beaver-Visitec International's BVI Leos Laser and Endoscopy System (Model OME6000U) has a manufacturing defect in the USB cable that connects the Nurse Monitor touchscreen to the System Controller. The cable is missing required ferrite components that protect against electromagnetic interference. Five units with specific serial numbers were affected and distributed in Florida, Michigan, Oklahoma, Texas, and Wisconsin.
- Check if your system serial number matches: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, or 77UBV500010
- Contact Beaver-Visitec International or your equipment supplier for inspection or replacement of the USB cable assembly
- Do not use the system if you confirm a match until the cable is corrected
The agency's original wording
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2026Want us to check the next one for you?
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