| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00034-1 |
| Product Name/Description |
syngo.plaza
(Radiology picture archiving/communication system)
Lot numbers: 10863171 & 10863173
ARTG number: 120332 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
In the event of a system crash (e.g. bluescreen, power outage) the image may not be written from cache to the file system and may be lost in syngo.plaza. When a further image is received, syngo.plaza will allocate the same file name for the new image, and after some internal checks it will add the entry to the database for the new image. This gives rise to two references in the database to the same image which may lead to either:
· The wrong image being displayed, which means for that series there is an image with a wrong examination parameter, and/or wrong examination (e.g. head/knee) and/or may be the wrong patient. This patient mix-up could lead to a wrong diagnosis, or
· Data loss in that an image is missing.
To date this issue has not been reported by Australian customers. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing a work around for customers whilst a permanent software fix is being developed. This action has been closed-out on 15/07/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |