United StatesBVI Leos Laser and Endoscopy System, model OME6000U (UDI (01)00886158037576(11)250513(21); serial numbers 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010) sold in FL, MI, OK, TX and WI is affected. The recall was issued because the ferrites specified for the USB cable linking the Nurse Monitor touchscreen to the System Controller were not installed as intended, causing the cable to not meet design specifications that require two ferrites (one at each end).
What's being recalled
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Recalling firm: Beaver-Visitec International, Inc., Waltham, MA, United States.
How to identify it
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
The 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).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)