| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00462-1 |
| Product Name/Description |
MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (picture archiving and communication system)
ARTG Number: 178437 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare has identified a software defect that results in incorrect display of absolute values when measuring pixel density and statistics for Region of Interest. This issue occurs when Enhanced MR and Enhanced CT images are sent to the PACS with modality LUT (Look Up Tables) as defined in DICOM functional group. There could be misdiagnosis if a clinician relies on the incorrect density measurements displayed. This issue does not affect images that are not enhanced image objects. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising their customer that they must configure the MRI and CT devices to send regular CT and MR DICOM image objects (not enhanced) to PACS. Philips is developing a software update to address the issue. This action has been closed-out on 18/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |