Device 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)
Z-2650-2023
Product summary
- Event
- Event 92945
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-2650-2023
Official wording
Reason: Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Code information: UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)