—#161520

Product

Syngo.via systems with SW VB20A

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123375
Affected lot / code info: 10496180

Why it was recalled

A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.

Root cause (FDA determination)

Software Design Change

Action the firm took

On August 25, 2017 an URGENT letter was issued to customers notify of a system update for Syngo.via systems with SW VB20A. The software was released on August 22, 2017. Several bugs and inconsistent diagnoses were detected and this software is intended to correct these. If you have any questions, call Siemens Customer Care Centre at 888-826-9702 (24/7).

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2017-08-31
Terminated: 2018-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161520. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.