Z-2261-2012Class II

Visual-ICE Cryoablation System, Model FPRCH 6000

Name: Z-2261-2012 Visual-ICE Cryoablation System, Model FPRCH 6000
Creator: Galil Medical, Inc.
Published: 2012-07-20
License: https://open.fda.gov/license/

Galil Medical Ltd. / initiated 2012-07-20 / Terminated / root cause: design

FDA source

Galil Medical, Inc. began a recall of Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of... on 2012-07-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2261-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-20
Posted: 2012-08-23
Terminated: 2012-09-13
Recalling firm: Galil Medical Ltd.
Product: 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.
Product code: GEH Unit, Cryosurgical, Accessories
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 4
Distribution: Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
Product codes and lots: VL0004 VL0014 VL0015 VL0016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2261-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2261-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-23

Product code GEH

K113860Class IIVisual-Ice Cryoablation SystemGalil Medical, Inc. / cleared 2012-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)