Recall Z-2261-2012— Galil Medical, Inc.

Name: FDA recall Z-2261-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-20

Class II · Terminated

Class II FDA medical device recall by Galil Medical, Inc., initiated 2012-07-20, terminated 2012-09-13. It names one FDA 510(k) clearance: K113860. 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.. 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..

Recalling firm: Galil Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-20
Terminated: 2012-09-13
Firm location: Arden Hills, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K113860 — VISUAL-ICE CRYOABLATION SYSTEMGalil Medical, Inc.·cleared 2012-03-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.