Jan

2018

Cl II Orthoscan Mobile Mini C-arm system

Company:OrthoScan Inc
Date of Enforcement Report 1/17/2018
Class lI:

PRODUCT

Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures..
Recall Number Z-0258-2018 to Z-0261-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
OrthoScan Inc., Scottsdale, AZ on 8/31/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2012 total

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Orthoscan Mobile Mini C-arm system

Amy Sellers

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