| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01110-1 |
| Product Name/Description |
MDC PACS R2.3 SP2 HF6 and MDC PACS R2.3 SP2 HF7 (Picture, archiving and communication system)
Serial Number: MCD121100431
ARTG Number: 207252 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
A software error exists that changes the Study Time sent from modalities when it ends in zero(es) and incorrectly displays it in the PACS work list. The result is that examinations are displayed with a study time of 00:00:00 or 24:00:00 instead of the actual time the study was taken at, resulting in the chronological order of these exams being incorrectly displayed. This incorrect display of study time/ incorrect chronological order may result in patient misdiagnosis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users to rely on the study time displayed in DiagNET viewer and not in the PACS client worklist in case studies acquired on the same date. A software update will be provided to permanently correct the issue. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |