| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00970-1 |
| Product Name/Description |
DRX Revolution Mobile, DRX Mobile Retrofit & DRX Transportable X-ray Systems
All lot numbers affected
ARTG Numbers: 194055 & 161988 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Carestream Health Australia has received reports from overseas of unusable diagnostic images on exams where a Normal Exposure Mode (NEM) view is exposed immediately prior to an Extended Exposure Mode (EEM) view with the system in Fast Preview Mode. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carestream Health Australia is providing a firmware update that will allow NEM and EEM images to be taken in any order. The update will be provided at the next scheduled service or within 3 months. Until the firmware upgrade is installed end users are advised to only perform the EEM acquisition prior to the NEM acquisition. |
| Contact Information |
02 8962 4914 - Carestream Health Australia |