| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00868-1 |
| Product Name/Description |
Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)
All Versions below 4.0.3
ARTG Number: 120196 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware of potential safety issues due to out of context and measurement issues associated with specific workflows of Centricity PACS RA1000 workstations. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare are providing a software update to correct the issue (version 4.0 SP3).The update can only be applied to versions 3.2.X and 4.01. Customers on previous versions must first upgrade to 3.2 before applying update 4.0 SP3. Once 4.0 SP3 (FMI 85285) is released, all media required to upgrade from 3.1.1.2 to 3.2 to 4.0 SP3 are included in the FMI 85285 media kit. Thia action has been closed on 28/01/2016 |
| Contact Information |
1800 659 465 - GE National Call Centre |