Reported Aug 29, 2012 · Terminated
Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is…
Galil Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Galil Medical, Inc. · 4364 Round Lake Rd W · Arden Hills, MN · 55112
Is this the product you have?
- Visual-ICE¿ Cryoablation System
- Model FPRCH 6000 Product UsageThe 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
- Lot codes and dates
- VL0004 VL0014 VL0015 VL0016
- Amount recalled
- 4
Where it was sold
- Nationwide
- MN
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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