Events

Recall of Device Recall VisualICE Cryoablation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Galil Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62871
  • Event Risk Class
    Class 2
  • Event Number
    Z-2261-2012
  • Event Initiated Date
    2012-07-20
  • Event Date Posted
    2012-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111916
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, cryosurgical, accessories - Product Code GEH
  • Reason
    Galil medical is recalling a number of visual ice cryoablation systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.
  • Action
    Galil Medical sent a "Voluntary Medical Device Field Correction" letter dated July 20, 2012, via UPS to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that a Galil Field Service team will be contacting customers to schedule a service visit the week of July 23rd. Customers were instructed to forward and communicate this field correction notice and instructions to individuals in their organization and/or to other organizations affected by this action. For questions call Galil Medical Customer Service.

Device

Device Recall VisualICE Cryoablation System
  • Model / Serial
    VL0004 VL0014 VL0015 VL0016
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
  • Product Description
    Visual-ICE¿ Cryoablation System, Model FPRCH 6000 || Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
  • Manufacturer
    Galil Medical, Inc.

Manufacturer

Galil Medical, Inc.
  • Manufacturer Address
    Galil Medical, Inc., 4364 Round Lake Rd W, Arden Hills MN 55112
  • Manufacturer Parent Company (2017)
    Btg Plc
  • Source
    USFDA