Icecure Medical Ltd is recalling 16 units of the IceCure Cryoablation System ProSense, specifically models FAS3000000 and FAS3000000-2, to provide an updated user manual. The recall was initiated because older versions of the manual lacked specific safety guidelines for handling mechanical damage, such as a bent cryoprobe. This system is used by medical professionals to destroy tissue during surgery using extreme cold. Owners of the device need to replace their current manuals with Revision E to ensure they have the necessary safety protocols to prevent equipment failure or patient injury.
If a healthcare provider uses a cryoprobe that has been mechanically damaged or bent without following the proper safety guidelines, it could lead to equipment failure or unintended tissue damage during a surgical procedure.
User Manual Update
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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