BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Summary
The FDA issued a Class II for BVI Leos Laser and Endoscopy System. Model Number: OME6000U. by Beaver-Visitec International, Inc.. Reason: Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were.
Details
Source
Device Recall
External ID
Z-1008-2026
Action Date
2026-01-07
Status
Ongoing
Category
device
Product Description
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Lot/Code Info: Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Quantity Affected: 5 units
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).
Distribution
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-05
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beaver-Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beaver-Visitec International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beaver-Visitec International, Inc. have FDA actions?
Beaver-Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1008-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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