Syngo.via software is intended to be used for viewing recall: Software Issue
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone…
Why was Syngo.via software is intended to be used for viewing recalled?
When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Syngo.via systems with VB20A. Model number 10496180.
- Product
- Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 165 units
- Distribution
- Medical device software which needs to be installed.
- Recall date
- April 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)