PROSENSE SYSTEM 100-127 VAC recallZ-2650-2023 · Icecure Medical Ltd · initiated Sep 16, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Icecure Medical Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
FDA root cause category: Other
What the company is doing
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]
Recall details
- Recall number
- Z-2650-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 16, 2019
- Posted by the FDA
- Sep 29, 2023
- Recalling firm
- Icecure Medical Ltd
- Quantity
- 16 units
- Product code
- GEH
- FDA submissions
- K102360
- Distribution
- US Nationwide distribution.
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)
Code information (models, lots, serial numbers)
UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- PROSENSE™ SYSTEM 100-127 VAC FAS3000000Icecure Medical Ltd · Unit, Cryosurgical, Accessories1 recall3 reports
- PROSENSE™ SYSTEM 100-127 VAC FAS3000000-2Icecure Medical Ltd · Unit, Cryosurgical, Accessories1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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