Beaver-Visitec International, Inc.: Device Recall

Recall Details

Recall Number

Z-1008-2026

Classification

Class II

Product Type

Device

Recalling Firm

Beaver-Visitec International, Inc.

Status

Ongoing

Date Initiated

12/05/2025

Location

Waltham, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

5 units

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).

Product Description

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Distribution Pattern

US Nationwide distribution in the states of FL, MI, OK, TX, WI.

Other Recalls by Beaver-Visitec International, Inc.

• Class II: Risk 07/26/2024
  Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
• Class II: Risk 07/26/2024
  Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
• Class II: Risk 07/26/2024
  Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
• Class II: Risk 07/26/2024
  Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
• Class II: Risk 07/26/2024
  Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.

View all recalls by Beaver-Visitec International, Inc. →