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)
This recall is currently active, issued September 29, 2023. It was issued by Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel.
- Recall Initiated
- September 16, 2019
- Posted
- September 29, 2023
- Recall Number
- Z-2650-2023
- Quantity
- 16 units
- Official Source
- View on FDA website ↗
Reason for Recall
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Distribution
US Nationwide distribution.
Lot / Code Info
UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.
Root Cause
Other
Action Taken
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 icecuresupport@icecure-medical.com