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.
FDA Recall Z-2261-2012 · Posted 2012-08-23
Recalling FirmGalil Medical, Inc.
Recall StatusTerminated
Product CodeGEH
Date Initiated2012-07-20
Date Terminated2012-09-13
Product Quantity4
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.