FDA Medical Device Recalls (openFDA)
Beaver-Visitec International, Inc.: BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
- Recall number
- Z-1008-2026
- Recalling firm
- Beaver-Visitec International, Inc.
- Product
- BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
- Status
- Open, Classified
- Initiated
- 2025-12-05
- Posted
- 2025-12-31
- Terminated
- not on file
- 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).
- Root cause
- Process control
- Action
- 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.
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states of FL, MI, OK, TX, WI.
- Lot, serial or model codes
- Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
- 510(k) numbers
- ["K240615"]
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28