Bvi Leos Laser And Endoscopy System. Model Number: Ome6000u.
Recall Summary The BVI Leos Laser and Endoscopy System (Model OME6000U) is being recalled because the USB cable connecting the Nurse Monitor touchscreen to the System Controller is missing ferrite components that were supposed to be installed at both ends of the cable. This manufacturing error means the device doesn't meet its design specifications. The recall affects all users of this system model.
- Recalling firm
- Beaver-Visitec International, Inc.
- Product
- BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
- Reason
- 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).
- Classification
- Class II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-12-05
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f5beface-b11d-4657-9141-7f6946b891a9