| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00992-1 |
| Product Name/Description |
Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10C
ARTG numbers – 102184, 102182 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Loss of images - If an automatic RIS worklist update is performed while a patient is already selected for examination, the subsequently acquired images of this patient might get lost under certain circumstances and cannot be recovered. This malfunction is not detectable to the user during the examination. Only after the patient study is opened in the “Examined Patients” list, the user will be able to recognize that the acquired images are not available and irreversibly lost.
Incorrect labels and annotations - Under certain circumstances the image label (L, R) and annotations are displayed incorrectly after images have been sent to PACS or hardcopy/filming. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens are working on a software update to correct both malfunctions. In the interim Siemens is providing the following work around instructions:
- To avoid the potential risk of lost images Siemens is advising their customers to disable the automatic RIS worklist update and perform this procedure manually.
- To ensure the correct orientation of images Siemens recommends to always use lead letters to indicate patient orientation on the x-ray image.This action has been closed-out on 06/06/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |