| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00442-1 |
| Product Name/Description |
Centricity PACS RA1000 Workstation versions 3.2 and higher (Picture archiving and communication system)
Software versions: 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 3.2 SP7, 3.2 SP8, 4.0, 4.0.1 & 4.0 SP3
ARTG number: 162031 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images from the previously displayed study may also be rejected. This issue can occur with a previously displayed study that remains open in the background.
There is a DelRejImg task in Centricity PACS versions 3.2 and higher, that if enabled and running, in conjunction with the inadvertently rejected image issue, poses a potential patient safety hazard due to data loss. If the DelRejImg task runs, the inadvertently rejected images will be permanently deleted from PACS. If you do not have the DelRejImg task running, there is no potential hazard since the inadvertently rejected images remain on the system. The deletion of the inadvertently rejected images could result in missed intervention or mis-diagnosis. No patient injuries have been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A future release of Centricity PACS will address the unintentional rejected image issue. Until the permanent fix for this issue is deployed, GE recommends customers implement workarounds identified in the customer letter. Also, a GE Healthcare service representative will remove the DelRejImg task from the task table in the Centricity PACS database. This will remove the rejected image deletion feature, and eliminate the hazard situation. Thia action has been closed-out on 28/01/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |