IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during recall — FDA Z-2650-2023
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Overview of recall records associated with Icecure Medical Ltd, including dates, categories and classifications where available.
Classification mix: Class II: 1.
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
This page summarizes recall records in which the official source identifies Icecure Medical Ltd as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.