BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 05, 2025 |
| Reported | January 07, 2026 |
| Recalling firm | Beaver-Visitec International, Inc. |
| Country / region | United States MA |
Hazard
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).
Affected products
- BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
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