medical Class II Updated 2023-10-11

Icecure Medical Ltd recalls IceCure Cryoablation System ProSense -Intended for cryogenic

Recalled 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)

Hazard / Issue

Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.
View official government recall

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