Galil Medical recalls Visual-ICE Cryoablation System FPRCH6000 models with potential needle clogging or inadequate freezing performance. Affected units include specific serial numbers and PM kits.
Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.
Galil Medical is recalling its Visual-ICE Cryoablation System (FPRCH6000) because needles may clog or not freeze tissue properly. This could lead to ineffective treatment or complications during medical procedures.
The system uses high-pressure argon gas to freeze tissue through needles. If needles clog or fail to freeze tissue adequately, the procedure may not work as intended, potentially causing ineffective treatment or complications.
Medical professionals using the Visual-ICE system for cryoablation procedures are most at risk. Patients undergoing the treatment may be affected if the system malfunctions.
Check for the system serial number (e.g., VL0031) and PM kit number (e.g., PM0506M) listed in the recall notice. The product is sold as a mobile console system for cryoablation procedures.
Review the system serial number and PM kit number to confirm if your device is affected.
It's a mobile console system for cryoablation tissue destruction using minimally invasive procedures.
Specific models with serial numbers like VL0031 and PM kit numbers like PM0506M are affected.
The recall record does not mention a remedy or fix for the issue.
We’ve drafted a message you can send Galil Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0404-2020 — Galil Medical Galil Medical Hello, I own a Galil Medical that is covered by recall Z-0404-2020 from Galil Medical. 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.
