| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00873-1 |
| Product Name/Description |
Merge iConnect Enterprise Archive (iCEA) with software versions: 5.30.0 and greater up to and including 9.4.3
(a picture archiving and communications system)
ARTG Number: 206683 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
This recall has been initiated because the impacted versions of iCEA allow images to be stored to the iCEA without pixel data.
- Image was retrieved by RadSuite from iCEA, a QC action was performed, & sent back to iCEA.
- Image was sent to iCEA with pixel data but the pixel data was not stored with the image to iCEA. The investigation found that there is a networking scenario where the network dropped the connection after sending the header information but before the pixel data arrived. iCEA stored the image without the pixel data.
- Image was sent to iCEA without pixel data & the image was stored to iCEA. The pixel data may have been lost by the device that sent the data to iCEA.
A side effect of images without pixel data is performance degradation caused by the system continuously attempting to route the images to the peer system that fail to store. There could be delay in treatment in determining the progression of disease. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is advising users that there is no work around for the issue, however the error is obvious to users using PACS viewer, as it is indicated that there is a missing image (slice) from the study. Users not using PACS viewer may not be notified of the error.
Emergo will be implementing a software upgrade as a permanent correction. This action has been closed-out on 22/02/2017. |
| Contact Information |
02 9006 1662 - Emergo Australia |