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Icecure Medical Ltd recalls IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the app
Recalled October 11, 2023 · FDA recall Z-2650-2023 · Icecure Medical
Hazard
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe) · FDA Class II
Units
16 units
Sold at
US Nationwide distribution.
Description
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Product
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)
Manufacturer(s)
Icecure Medical Ltd
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →