Orthoscan, Inc. recalls Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of…

Recall date

August 31, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0258-2018

FDA classification

Class II

Brand / firm

Orthoscan, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Po…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.