Events

Recall of ORTHOSCAN HD MODEL 1000-0001 MINI C-ARM X-RAY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHOSCAN INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    88255
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Devices do not meet iec/en 60601-2-54 203.8.5.3 with respect to use of the digital zoom mode if user follows a non-standard workflow. the system will expose a larger x-ray field than allowed beyond the image receptor field of view displayed on the monitor of the system by > 3% of sid. known aug 2017.

Device

ORTHOSCAN HD MODEL 1000-0001 MINI C-ARM X-RAY SYSTEM
  • Model / Serial
    Model Catalog: 1000-0001 (Lot serial: all lots. contact mfg); Model Catalog: 1000-0005 (Lot serial: all lots. contact mfg.); Model Catalog: 1000-0001 (Lot serial: all lots. contact mfg.); Model Catalog: 1000-0004 (Lot serial: all lots. contact mfg.); Model Catalog: 1000-0004-FD (Lot serial: all lots. contact mfg.)
  • Product Description
    Orthoscan HD Model 1000 Mini C-arm X-Ray System
  • Manufacturer
    ORTHOSCAN INC.

Manufacturer

ORTHOSCAN INC.
  • Manufacturer Address
    SCOTTSDALE
  • Source
    HC