Reported Jan 7, 2026 · Ongoing
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Beaver-Visitec International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beaver-Visitec International, Inc. · 500 Totten Pond Rd · Waltham, MA · 02451-1916
Is this the product you have?
- BVI Leos Laser and Endoscopy System
- Model NumberOME6000U
- Lot codes and dates
- Model NumberOME6000U
- UDI(01)00886158037576(11)250513(21)
- Serial Numbers
77UBV50000377UBV50000477UBV50000577UBV50000677UBV500010
- Amount recalled
- 5 units
Where it was sold
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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