FDAFDA · Food and drugs·Recall number Z-2261-2012
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.
Published August 29, 2012 · Recall initiated: July 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Galil Medical, Inc.
- Distributor
- Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
- Lot
- VL0004 VL0014 VL0015 VL0016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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