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U.S. Department of Health and Human Services

Class 2 Device Recall IceCure Family Cryoablation System

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 Class 2 Device Recall IceCure Family Cryoablation Systemsee related information
Date Initiated by FirmSeptember 16, 2019
Date PostedSeptember 29, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2650-2023
Recall Event ID 92945
510(K)NumberK102360 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductIceCure 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)
Code Information UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.
Recalling Firm/
Manufacturer		 Icecure Medical Ltd
7, Ha-Eshel
Caesarea Israel
Manufacturer Reason
for Recall		Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
FDA Determined
Cause 2		Other
ActionIceCure 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 in Commerce16 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEH
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