Z-2650-2023Class II

IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures...

Name: Z-2650-2023 IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures...
Creator: Icecure Medical Ltd
Published: 2019-09-16
License: https://open.fda.gov/license/

Icecure Medical Ltd / initiated 2019-09-16 / Open, Classified

FDA source

Icecure Medical Ltd began a recall of IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures... on 2019-09-16. FDA classified it as Class II and gives the reason as "Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2650-2023
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-16
Posted: 2023-09-29
Recalling firm: Icecure Medical Ltd
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)
Product code: GEH Unit, Cryosurgical, Accessories
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 root cause: Other
Action: IceCure 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 [email protected]
Quantity in commerce: 16 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2650-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2650-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29

Product code GEH

K102360Class IIIcesence 3IceCure Medical , Ltd. / cleared 2010-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)