[pending] BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Pending LLM rewrite. Source: FDA_DEVICE Z-1008-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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).
The recalled product
- Product
- BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
- Manufacturer
- Beaver-Visitec International, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 77UBV500004
- 77UBV500005
- 77UBV500006
- 77UBV500010.
Distribution
Distributed nationwide across the United States.
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