Pre-procedural issues related to software defects
Pre-procedural issues related to software defects
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 Edwards Lifesciences, LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-0496-2018 — Edwards Lifesciences, LLC Edwards Lifesciences, LLC recalls Hemosphere System with the following th Hello, I own a Edwards Lifesciences, LLC recalls Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and that is covered by recall Z-0496-2018 from Edwards Lifesciences, LLC. 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.
