Z-1008-2026Class II

BVI Leos Laser and Endoscopy System. Model Number: OME6000U

Name: Z-1008-2026 BVI Leos Laser and Endoscopy System. Model Number: OME6000U
Creator: Beaver-Visitec International, Inc.
Published: 2025-12-05
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2025-12-05 / Open, Classified / root cause: manufacturing process

FDA source

Beaver-Visitec International, Inc. began a recall of BVI Leos Laser and Endoscopy System. Model Number: OME6000U on 2025-12-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1008-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-05
Posted: 2025-12-31
Recalling firm: Becton Dickinson & Co
Product: BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Product code: HQF Laser, Ophthalmic
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).
Root cause tag: manufacturing process
FDA 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 in commerce: 5 units
Distribution: US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Product codes and lots: Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1008-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1008-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-07	2025-12-31

Product code HQF

K240615Class IILeos Laser and Endoscopy SystemBeaver-Visitec International, Inc. / cleared 2025-04-03

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)