Visao® 3318606Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994436355), received between Nov 22, 2019 and Nov 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081277); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2019Loose or Intermittent Connection; Blocked Connection; Loose or Intermittent Connection; Blocked Connection

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE TUBING BECAME LOOSE AND AIR BUBBLE KEPT BEING INTRODUCED IN THE COOLANT TUBING WHICH LEAD TO THE HANDPIECE OVERHEATING PRIOR A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THE TUBING WAS DISCONNECTED PRIOR TO DRILLING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9361247 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E