| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00391-1 |
| Product Name/Description |
Mobile Digital X-Ray GM60A
Serial Numbers: 509RM9BGB00001 and 509RM9BGB00002
ARTG Number: 229491 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Samsung has been notified of an issue of over exposed X- Ray images. The investigation revealed that mAs value had increased without any interaction of the user even when the correct protocol had been followed by the operator. It's been observed from log files analysis that the mAs values had increased during the examination and had showed that patients received different dose values than what was stored in the pre-defined protocols. It is discovered that the touch screen is sensitive to unintended touch which may occur if any liquid/ foreign bodies are on the screen. It had also been identified that in these particular incidents, the tube cable had touched the mSec up button when the tube head unit of GM60A was at the parked position. Protocols were set before the device had been moved & positioned by the patient. Whilst the device was moved, the cable had touched the panel and increased the exposure condition to the maximum value. This may lead to unintended exposure to the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Samsung has developed a software update which will be implemented by a trained service engineer who will attend the users' premises. In the interim, Samsung is recommending users ensure that the GM60A system is moved into position before parameters are set and that there are no obstructions to the touchscreen which may cause an increase in values during the examination and to always ensure that the correct exposure levels have been set before exposure to the patient.
This action has been closed-out on 27/03/2018. |
| Contact Information |
02 9763 9700 - Samsung Australia |