—#217578

Product

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

FDA product code: HQF — Laser, Ophthalmic
Device class: Class 2
Medical specialty: Ophthalmic
510(k) numbers: K240615
Affected lot / code info: Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.

Why it was 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).

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Beaver-Visitec International, Inc.
Address: 500 Totten Pond Rd, Waltham, Massachusetts 02451-1916

Distribution

Distribution pattern: US Nationwide distribution in the states of FL, MI, OK, TX, WI.

Timeline

Recall initiated: 2025-12-05
Posted by FDA: 2025-12-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217578. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.