BVI Leos Laser and Endoscopy System recall
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Why was BVI Leos Laser and Endoscopy System recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
- Product
- BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
- Recalling firm
- Beaver-Visitec International, Inc.
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states of FL, MI, OK, TX, WI.
- Recall date
- January 7, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)