Galil Medical, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2261-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 20, 2012

Date Posted: August 29, 2012

Recall Number: Z-2261-2012

Event ID: 62871

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.

Status: Terminated

Product Quantity: 4

Code Information:

VL0004 VL0014 VL0015 VL0016

Distribution Pattern:

Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated