Model note · Cryotherapy System
Boston Scientific Visual-ICE Cryoablation System
Visual-ICE is a mobile cryoablation console for minimally invasive destruction of tissue, such as tumours, through percutaneous needles under image guidance. High-pressure argon circulates through closed-tip needles to form an iceball, and tissue is thawed with helium or with a heating element inside i-Thaw needles. It can run up to 20 needles on 10 channels with four multi-point thermal sensors on a single console.
The model
Maker, model and type.
- Maker
- Boston Scientific Corporation (originally Galil Medical, later BTG)
- Model
- Visual-ICE Cryoablation System (console FPRCH6000)
- Device type
- Cryotherapy System
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Freezing and thawing | High-pressure argon through closed-tip needles to freeze; helium or i-Thaw needle heating element to thaw | Source |
| Needle capacity | Up to 20 needles across 10 channels | Source |
| Temperature monitoring | 4 multi-point Thermal Sensors | Source |
| Display | 19 inch HD touchscreen | Source |
| Thaw modes | Helium thaw, helium-free i-Thaw and FastThaw; CX needles also support track ablation | Source |
| Maximum gas supply pressure | 6000 psi (414 bar); higher supply can damage internal parts | Source |
| Needle families | Various diameters such as 1.5 mm and 2.1 mm; i-Thaw and CX needles | Source |
| FDA clearance | 510(k) K230551 (2023), product code GEH; earlier K113860, K123865, K143564 | Source |
Recalls
Known FDA recalls.
- Z-0287-20212020-09-22
Visual-ICE MRI Mobile Connection Panel with incorrectly installed base.
FDA record - Z-2678-20202020-06-04
IceFORCE and IcePearl 2.1 CX needle surface deteriorated from electrolysis.
FDA record - Z-0404-20202019-10-25
Needle clogging or poor freezing with IceSeed 1.5 and IceRod 1.5 PLUS needles; desiccant tube PM required.
FDA record - Z-2261-20122012-07-20
Gas regulators may fail to regulate pressure, making systems inoperable.
FDA record
Safety
Safety warnings from the record.
- A needle with a gas leak can cause a gas embolism; never use a bent, damaged or bubbling needle. Source
- Lock each needle into its channel before starting, or gas pressure may eject it forcefully. Source
- Chain gas cylinders to a wall or approved cart, and do not force a gauge or line that resists, as it may still be under pressure. Source
- Cold needle tubing and hot needles during active thaw or cautery can injure skin and non-target tissue. Source
- The system must not be used near MRI equipment, and only non-MRI needles may be used with it. Source
Sources
Where this note comes from.
- Boston Scientific, Visual ICE product page (EU)
- Boston Scientific, Visual-ICE indications, safety and warnings (US)
- FDA 510(k) summary K230551, Visual-ICE
- openFDA recall search, Visual-ICE
- openFDA MAUDE problem counts, Visual-ICE
Not covered: The operator's manual and service manual were not found publicly, so system alert messages, working pressure limits (Table 5 of the IFU) and the PM schedule are not included; no error code list is public.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Cryotherapy System
Other models of this device.
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