Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Biosense Webster, Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0210-2018 — Biosense Webster, Inc. Biosense Webster, Inc. recalls SMARTABLATE RF System Generator Hello, I own a Biosense Webster, Inc. recalls SMARTABLATE RF System Generator that is covered by recall Z-0210-2018 from Biosense Webster, Inc.. 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.
