IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the app
FDA device recall Z-2650-2023 · posted 2023-09-29 · Open, Classified
Recall details
- Recalling firm
- Icecure Medical Ltd
- Reason for recall
- Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
- Action taken
- 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 icecuresupport@icecure-medical.com
- Root cause
- Other
- Status
- Open, Classified
- Product code
- GEH
- Quantity affected
- 16 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2019-09-16
- Date posted
- 2023-09-29
- Location
- Caesarea, Israel
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ICESENCE 3 (K102360) | IceCure Medical , Ltd. | 2010-11-29 |