| 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 |
|
| 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 |