Visual-ICE¿ Cryoablation System — Class II medical device recall Z-2261-2012
Terminated recall by Galil Medical, Inc., reported 2012-08-29, distributed nationwide. Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to
| Recall number | Z-2261-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Galil Medical, Inc., Arden Hills, MN, United States |
| Recall initiated | 2012-07-20 |
| Classified | 2012-08-23 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2012-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, NL |
| Quantity | 4 |
| Reason classes | device malfunction |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.