| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00443-1 |
| Product Name/Description |
syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC)
(Radiology information system)
Catalogue number: 10558586
ARTG number: 142663 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
While configured for the batching of orders, when an order transaction is received from a HIS interface, it is temporarily read into the system while waiting for the next transaction to come across the interface. If the next transaction is another procedure for the same patient, it would be "batched" with the first order until a transaction that is not an order for the "batched" patient is received or the maximum wait time of 10 seconds is exceeded. At this point, all the order(s) would be processed.
If the system receives a shutdown request to restart the interface process while an order is within this 10 second "batching" window, the order may be lost with no indication to the user. This condition can happen when a user manually attempts to restart the interface process or when all of the application processes are restarted during the day-end processing sequence. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The issue can be avoided by not using the Order Batching feature. If the Order Batching feature is used. Users are recommended to configure the day-end processing to take place at the time with the anticipated lowest number of order transactions until the issue is solved in the software.For new upgrades or new installations, the issue will be solved in the syngo Workflow SLR software version VB20A_HF01 which is planned to be released in 02/2015.
For existing VA31, VA32, VB10, and VB20A sites, the issue will be resolved following Safety Update Instruction SY038/15/S which is planned to be released in 02/2015. This action has been closed-out on 31/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |