Recall Z-2650-2023— Icecure Medical Ltd
Class II · Ongoing
Class II FDA medical device recall by Icecure Medical Ltd, initiated 2019-09-16. It names one FDA 510(k) clearance: K102360. 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: Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe).
- Recalling firm
- Icecure Medical Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-09-16
- Firm location
- Caesarea, N/A, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.