IceCure Cryoablation System ProSense -Intended for recall
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold…
Why was IceCure Cryoablation System ProSense -Intended for recalled?
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.
- Product
- IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold…
- Recalling firm
- Icecure Medical Ltd
- Quantity
- 16 units
- Distribution
- US Nationwide distribution.
- Recall date
- October 11, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)