BVI Leos Laser and Endoscopy System. Model Number: OME6000U. (Beaver-Visitec International, Inc.) – manufacturing deviation in which the ... (2025)
Missing ferrites on a USB cable may cause minor communication specification non-conformance.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Brand
Beaver-Visitec International, Inc.
Lot Codes / Batch Numbers
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Products Sold
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Beaver-Visitec International, Inc. is recalling BVI Leos Laser and Endoscopy System. Model Number: OME6000U. due to Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Beaver-Visitec International (BVI) notified consignees via emailed letter on 12/05/2025. Consignees were informed that the affected units can still be used. A BVI service technician will contact each consignee to schedule a visit. During this visit, the missing ferrites will be installed to restore the equipment to its fully compliant and validated configuration. BVI aims to complete the correction by December 31st, 2025.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026