The video cytoscopes lack 510(k) premarket notification clearance.
The video cytoscopes lack 510(k) premarket notification clearance.
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 Pentax of America Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-0615-2018 — Pentax of America Inc Pentax of America Inc recalls Video Cystoscope models ECY-1570 and ECY-1570K Hello, I own a Pentax of America Inc recalls Video Cystoscope models ECY-1570 and ECY-1570K that is covered by recall Z-0615-2018 from Pentax of America 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.
