HIGHFDA DEVICE
Beaver-Visitec Recalls Laser and Endoscopy System Over Safety Hazard
Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.
Beaver-Visitec International
Manufacturing deviation