Caesarea, N/A, Israel
Icecure Medical Ltd recalls
1 recall recorded since 2018, most recently on 16 September 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 September 2019
- Reason
- Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2650-2023
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.