| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00482-1 |
| Product Name/Description |
Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communication system)
ARTG number: 164422 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
The “Switch User” feature is an option in Windows 7 that allows another user to open a new session with his user account without requiring the previous user to log out of the existing session. It has been discovered that running the same Synapse CV Client application under more than one Windows user account simultaneously may cause outbound HL7 reports with incorrect data to be sent to EMR. There is the potential that patients’ medical records may be altered as a result of utilizing this Windows 7 function through the unintentional modification of the outbound HL7 files. This issue does not occur if individual users logout of Windows 7. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Fujifilm does not support the use of the “Switch User” function in Windows 7 with Synapse CV. The function should be disabled on Windows 7 workstations that operate the Synapse CV application. There are several options to allow multiple users on a workstation and, if required, Fujifilm Customer Support will assist users with determining which option is best suited for each facility. |
| Contact Information |
02 9466 2600 - FUJIFILM Customer Support |