OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
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 Orthoscan, Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0259-2018 — Orthoscan, Inc. Orthoscan, Inc. recalls Mobile Mini C-arm system Part # 1000-0004. Intended to prov Hello, I own a Orthoscan, Inc. recalls Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of that is covered by recall Z-0259-2018 from Orthoscan, 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.
