Reported Oct 11, 2023 · Ongoing
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the…
Icecure Medical Ltd.
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: Icecure Medical Ltd · 7, Ha-Eshel · Caesarea, N/A · N/A
Is this the product you have?
- IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application
- of extreme cold temperatures Models
(1)FAS3000000 (100-127 VAC)(2)FAS3000000-2 (100-127 VAC)
- Lot codes and dates
- UDI(1)FAS3000000
- UDI07290015487160 (2)FAS3000000-2
- UDI07290015487290 All User Manual Revisions up to Rev.D
- Amount recalled
- 16 units
Where it was sold
- Nationwide
Why it was recalled
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
This product could cause temporary or reversible health problems — stop using it.
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