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)
FDA Recall Z-2650-2023 · Posted 2023-09-29
Recalling FirmIcecure Medical Ltd
Recall StatusOpen, Classified
Product CodeGEH
Date Initiated2019-09-16
Product Quantity16 units
Reason for Recall
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Firm Action
IceCure notified users on Sep.16th,2019 via email. IceCure Medical has updated the User Manual DSR3200000 Rev. E to include safety guidelines in case of any mechanical damage (e.g. bent cryoprobe) the cryoprobe.
Letter states reason for recall, health risk and action to take:
The user manual can be found at IceCure Medical website or If you would like to acquire our paper form user manual book, please contact us directly and one will be sent to you within 7 working days. We can be reached at +1-646-844-3066 or via email at [email protected]
Root Cause
Other
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.