An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
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 Fujifilm Medical Systems U.S.A., Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-3225-2017 — Fujifilm Medical Systems U.S.A., Inc. Fujifilm Medical Systems U.S.A., Inc. recalls FUJINON ED-530X Hello, I own a Fujifilm Medical Systems U.S.A., Inc. recalls FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically that is covered by recall Z-3225-2017 from Fujifilm Medical Systems U.S.A., 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.
