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U.S. Department of Health and Human Services

Class 2 Device Recall BVI Leos Laser and Endoscopy System

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 Class 2 Device Recall BVI Leos Laser and Endoscopy Systemsee related information
Date Initiated by FirmDecember 05, 2025
Date PostedDecember 31, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1008-2026
Recall Event ID 98076
510(K)NumberK240615 
Product Classification Laser, ophthalmic - Product Code HQF
ProductBVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Code Information Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
FEI Number 1211998
Recalling Firm/
Manufacturer		 Beaver-Visitec International, Inc.
500 Totten Pond Rd
Waltham MA 02451-1916
For Additional Information ContactSilvana Brown
952-737-7242
Manufacturer Reason
for Recall		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).
FDA Determined
Cause 2		Process control
ActionBeaver-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 in Commerce5 units
DistributionUS Nationwide distribution in the states of FL, MI, OK, TX, WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HQF
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