The device had an incorrect printed calibration value on the calibration certificate.
The device had an incorrect printed calibration value on the calibration certificate.
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 Carl Zeiss Meditec AG to request your refund or repair — edit it as you like.
Subject: Recall Z-0001-2018 — Carl Zeiss Meditec AG Carl Zeiss Meditec AG recalls Carl Zeiss INTRABEAM PRS 500, product #304534-0 Hello, I own a Carl Zeiss Meditec AG recalls Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, that is covered by recall Z-0001-2018 from Carl Zeiss Meditec AG. 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.
