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Recall Observatory FDA recall evidence

Device 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 device or together with a variety of cleared and unmodified syngo based software options.

Z-1261-2018

January 10, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 79513
Status
Terminated
Classification
Class II
Quantity
165 units
Official record key
device-enforcement:Z-1261-2018

Official wording

Reason: 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.

Code information: All Syngo.via systems with VB20A. Model number 10496180.

Distribution pattern: Medical device software which needs to be installed.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.