—#162538

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123375
Affected lot / code info: All Syngo.via systems with VB20A. Model number 10496180.

Why it was 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.

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

Customers received letters with information related to the issue and regarding the upgrade to the software version VB20A_HF04. The software was released December 22, 2017 and is available for install.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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

Timeline

Recall initiated: 2018-01-10
Terminated: 2018-10-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162538. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.