FDA recall Z-2650-2023

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)

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.

Key facts

Status

Ongoing

Initiation date

2019-09-16

Report date

2023-10-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Caesarea, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2650-2023