Recall Z-1008-2026— Beaver-Visitec International, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beaver-Visitec International, Inc., initiated 2025-12-05. It names one FDA 510(k) clearance: K240615. Product: BVI Leos Laser and Endoscopy System. Model Number: OME6000U.. Reason: 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)..
- Recalling firm
- Beaver-Visitec International, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-05
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.