FDA-Device2023-10-11Class II
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)
Icecure Medical Ltd
Hazard
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Sold states
US Nationwide distribution.
Affected count
16 units
Manufactured in
7, Ha-Eshel, N/A, Caesarea, N/A, Israel
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2650-2023Don't want to check this manually?
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