| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00653-1 |
| Product Name/Description |
GC80 Diagnostic X-Ray system
All Serial/Lot Numbers
ARTG Number: 224370 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
An incident had been reported in Germany to Samsung Electronics on 15 Dec 2016 where an image was obtained with over exposure during a thorax examination using the AEC function. The exposure condition was: 125kV, 180mAs.
As a result of the malfunction of the AEC, irradiation may not terminate properly which can cause exposure until the AEC back up time which is set at 500mSec by default. This can cause overexposure for users. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Samsung will be implementing a software update on affected units in early July 2017. In the interim, users are advised that they may continue to use the GC80 system, taking precaution of any possible network disconnection between the THU and WS. Users are requested to check 1) the THU connection status when using the system and 2) the THU connection before logging in after system booting. (Please refer to recall notification for images and further details).
This action has been closed out on 07/11/2018 |
| Contact Information |
02 9763 9700 - Samsung Australia |