🔍 RecallPedia

Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively , by the use of Galil Medical I-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

Class I - Dangerous
🏥 Medical Devices Recalled: October 25, 2019 Galil Medical Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    System Serial Number / PM Kit #: VL0031 / PM0506M, VL0036 / PM0546M, VL0067 / PM0515M, VL0069 / PM0565M, VL0075 / PM0532M, VL0079 / PM0539M, VL0082 / PM0491M, VL0085 / PM0486M, VL0086 / PM0499M, VL0088 / PM0489M, VL0090 / PM0513M, VL0092 / PM0548M, VL0093 / PM0544M, VL0094 / PM0520M, VL0100 / PM0516M, VL0102 / PM0529M, VL0105 / PM0560M, VL0112 / PM0542M, VL0115 / PM0525M, VL0136 / PM0561M, VL0148 / PM0514M, VL0153 / PM0531M, VL0171 / PM0564M, VL0175 / PM0559M, VL0181 / PM0512M, VL0186 / PM0533M, VL0191 / PM0492M, VL0220 / PM0545M, VL0230 / PM0528M, VL0238 / PM0500M, VL0249 / PM0498M, VL0271 / PM0497M, VL0275 / PM0543M, VL0280 / PM0549M, VL0283 / PM0488M, VL0285 / PM0566M, VL0287 / PM0562M, VL0291 / PM0524M, VL0300 / PM0550M, VL0301 / PM0541M, VL0303 / PM0530M, VL0304 / PM0563M, VL0308 / PM0523M, VL0309 / PM0507M, VL0310 / PM0490M, VL0311 / PM0555M, VL0312 / PM0526M, VL0321 / PM0552M, VL0362 / PM0527M.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Galil Medical, Inc.
Reason for Recall:
Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively , by the use of Galil Medical I-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

Product Codes/Lot Numbers:

System Serial Number / PM Kit #: VL0031 / PM0506M, VL0036 / PM0546M, VL0067 / PM0515M, VL0069 / PM0565M, VL0075 / PM0532M, VL0079 / PM0539M, VL0082 / PM0491M, VL0085 / PM0486M, VL0086 / PM0499M, VL0088 / PM0489M, VL0090 / PM0513M, VL0092 / PM0548M, VL0093 / PM0544M, VL0094 / PM0520M, VL0100 / PM0516M, VL0102 / PM0529M, VL0105 / PM0560M, VL0112 / PM0542M, VL0115 / PM0525M, VL0136 / PM0561M, VL0148 / PM0514M, VL0153 / PM0531M, VL0171 / PM0564M, VL0175 / PM0559M, VL0181 / PM0512M, VL0186 / PM0533M, VL0191 / PM0492M, VL0220 / PM0545M, VL0230 / PM0528M, VL0238 / PM0500M, VL0249 / PM0498M, VL0271 / PM0497M, VL0275 / PM0543M, VL0280 / PM0549M, VL0283 / PM0488M, VL0285 / PM0566M, VL0287 / PM0562M, VL0291 / PM0524M, VL0300 / PM0550M, VL0301 / PM0541M, VL0303 / PM0530M, VL0304 / PM0563M, VL0308 / PM0523M, VL0309 / PM0507M, VL0310 / PM0490M, VL0311 / PM0555M, VL0312 / PM0526M, VL0321 / PM0552M, VL0362 / PM0527M.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0404-2020

Related Recalls

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.

Galil Medical

Class I - Dangerous

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.

Jul 20, 2012 Surgical Instruments Nationwide View Details →