Z-1008-2026 Class II Ongoing
FDA device recall Z-1008-2026 was initiated by Beaver-Visitec International, Inc. on December 5, 2025 and is designated Class II. 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 fe… The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 7, 2026
- Initiation Date
- December 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
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 Pattern
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Code Information
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.