Icecure recalls ProSense cryoablation systems for potential mechanical damage risks. Updated manual addresses safety if cryoprobe bends. Affected models include FAS3000000 and FAS3000000-2 with specific UDI numbers.
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Icecure is recalling its ProSense cryoablation systems due to a safety update for mechanical damage risks. If the cryoprobe bends, the updated manual provides safety guidelines to prevent injury during surgical procedures.
The system has a risk of mechanical damage, such as a bent cryoprobe, which could lead to safety issues during surgical procedures. The updated manual provides safety guidelines to address this specific scenario.
Surgical teams using Icecure ProSense cryoablation systems with models FAS3000000 or FAS3000000-2 are affected. Patients undergoing cryogenic tissue destruction procedures are at risk if the cryoprobe bends.
Check for models FAS3000000 (100-127 VAC) or FAS3000000-2 (100-127 VAC) with UDI numbers 07290015487160 or 07290015487290. The recall applies to all versions up to User Manual Revision D.
Verify your system's user manual revision is up to D; if it's higher, contact Icecure for updates.
The recall is for a safety update to address mechanical damage risks, such as a bent cryoprobe, which requires updated safety guidelines.
Models FAS3000000 and FAS3000000-2 with UDI numbers 07290015487160 and 07290015487290 are affected.
No, the recall requires checking the manual revision and following updated safety guidelines if mechanical damage occurs.
We’ve drafted a message you can send Icecure to request your refund or repair — edit it as you like.
Subject: Recall Z-2650-2023 — Icecure Icecure Hello, I own a Icecure that is covered by recall Z-2650-2023 from Icecure. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
