BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Reported: January 7, 2026 Initiated: December 5, 2025 #Z-1008-2026
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).
Details
- Recalling Firm
- Beaver-Visitec International, Inc.
- Units Affected
- 5 units
- Distribution
- US Nationwide distribution in the states of FL, MI, OK, TX, WI.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.. Recalled by Beaver-Visitec International, Inc.. Units affected: 5 units.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 7, 2026. Severity: Moderate. Recall number: Z-1008-2026.
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