Recall Z-2650-2023 ยท GEH Unit, Cryosurgical, Accessories
Icecure Medical Ltd
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)
| Date | Sep 29, 2023 (initiated Sep 16, 2019) |
| Status | Open, Classified |
| Reason | Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe) |
| Root cause | Other |
| 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 icecuresupport@icecure-medical.com |
| Quantity | 16 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102360 | ICESENCE 3 IceCure Medical , Ltd., Nov 29, 2010 |