| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00097-1 |
| Product Name/Description |
syngo Workflow MLR
Catalogue Lot number: 10014099
ARTG Number: 184557 - cancelled
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
While creating or modifying a report using Microsoft Word application in Classic Client, when content is pasted form an external source including the formatting 'section break' or by inserting it manually, data from the pre-defined sections of the template might not be saved to the syngo Workflow MLR database. This incomplete report from the database issued for distribution to external systems e.g. HIS, PACS or Fax.
In the Classic Client Report Viewer the content is complete.
To date, no harm has been reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens is preparing a correction to rectify this issue. In the interim, users are advised to always use the standard report creating options of syngo Workflow MLR Classic Client:
1. Use the online speech recognition to dictate the report with the supplied microphone.
2. Type content in the report editor.
3. Use auto text module to speed up the reporting process.
4. Only copy/paste from ASCII view of prior reports in syngo Workflow MLR Classic Client.
In the case that users cannot avoid copy and pasting within the same document or from external applications, on all syngo Workflow MLR workstations the default paste option of the Microsoft Word application shall be set to 'KeepTextOnly'. Users may refer to the Customer Letter for further instructions regarding this.
In the event that a report was created using copy and paste, users should always verify the content for completeness. Instructions for this are provided in the Customer Letter.
This action has been closed out on the 08/11/2018. |
| Contact Information |
1800 310 300 - Customer Service Support |