Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 29, 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
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Galil Medical, Inc. recalled Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Vis… - a moderate-severity action.
Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Vis… was recalled by Galil Medical, Inc. in August 29, 2012. Reason: Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to…. Check the official notice for the remedy. Verify recall #Z-2261-2012 with the FDA Devices before acting.
The recall
Galil Medical, Inc. issued this moderate-severity FDA Devices recall-Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to….
- Moderate
- severity level
- 4 units
- affected scope
- Class II
- classification
- August 29, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2261-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2261-2012) was formally reported on August 29, 2012, with the manufacturer initiating the action on July 20, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Galil Medical, Inc. is listed as the recalling firm, operating out of Arden Hills, MN. Federal records list the affected scope as 4.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2261-2012 |
| Date reported | August 29, 2012 |
| Date initiated | July 20, 2012 |
| Recalling firm | Galil Medical, Inc. |
| Firm location | Arden Hills, MN |
| Affected scope | 4 |
| Distribution | Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2261-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Galil Medical, Inc.. Units affected: 4.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2012. Severity: Moderate. Recall number: Z-2261-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2261-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 29, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.