PlainRecalls
FDA Devices Moderate Class II Terminated

Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.

Reported: April 4, 2018 Initiated: January 10, 2018 #Z-1261-2018

Product Description

Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.

Reason for Recall

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.

Details

Units Affected
165 units
Distribution
Medical device software which needs to be installed.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 165 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1261-2018.