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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00339-1
Product Name/Description OrthoScan Mini C-Arm X-Ray Systems

Multiple Model and Serial Numbers

ARTG Number: 157136
(Medical & Optical Instruments Australia - X-ray system, diagnostic, fluoroscopic, general-purpose, portable, digital)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 24/04/2018
Responsible Entity Medical & Optical Instruments Australia Pty Ltd
Reason/Issue The manufacturer OrthoScan, has identified that the device does not fully meet the requirements of IEC EN 60601-2-54 with respect to specified workflows and the use of Digital Zoom mode. 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.
To date, there are no reports of injury as a result of this issue.
Recall Action Product Defect Correction
Recall Action Instructions Medical + Optical Instruments is advising that they will be in contact with customers to arrange installation of a new software version which will restore compliance of the device.

In the interim, users may continue to use their affected system by taking the following measures:
· When visualising the image with magnification, users should only select Digital Zoom as part of a post image capture operation whereby the Fluoroscopic X-ray beam is not active;
· Alert all staff members working with the device that they should never select the Digital Zoom while the Fluoroscopic x-ray beam is active;
· Staff are familiarised with the proper workflows to avoid the potential hazard of selecting Digital Zoom when the Fluoroscopic x-ray beam is active.

This action has been closed out on 09/07/2019
Contact Information 1800 225 065 - Medical + Optical Instruments