| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00952-1 |
| Product Name/Description |
IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)
All versions of IntelliSpace PACS 4.4 with Auto Export Feature Enabled are affected
ARTG Number: 178437 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
In Philips IntelliSpace PACS 4.4, there is feature which allows the optional configuration of Auto Export of resolved study exception immediately after resolution. When this configuration is used, it is possible for a system timing issue to occur when exporting data to 3rd party devices. If this system timing issue occurs when demographics are updated, such as during exception resolution and the study is immediately exported, the patient demographic information can be incorrect in the exported data.
Although the data is correct in IntelliSpace PACS if diagnosis is performed on this exported data using a 3rd party device the user may not be aware of unchanged patient data is being utilised. If this were to occur diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient. The hazard involved is that diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Each site will be contacted by Philip’s Technical Account Manager and notified if Auto Export is configured at the site and to schedule either the disabling or the correction of the Auto Export Feature. Determined by site utilization of the feature, Philips will schedule and deploy software correction or will disable the Auto Export Feature for all IntelliSpace 4.4 installations impacted by this issue. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |