Beaver-Visitec International, Inc. has recalled 5 units of the BVI Leos Laser and Endoscopy System (Model OME6000U) because ferrites, which act as filters to prevent electronic interference, were not installed on the USB communication cable. The omission of these parts means the system does not meet its design safety and performance specifications. This missing component affects the connection between the touchscreen monitor and the main system controller.
The missing ferrites can result in electromagnetic interference that may disrupt critical communication between the system components. This disruption could potentially cause device malfunctions during laser or endoscopic medical procedures.
Recall Number: Z-1008-2026. Manufacturing deviation in which the ferrites specified for the USB cable assembly were not installed.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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