—#163815

Product

Syngo.Via VB20A model 1049610

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

Why it was recalled

Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.

Root cause (FDA determination)

Software design

Action the firm took

On 03/27/18 Firm became aware that recall was necessary Firm initiated recall on 03/27/18 via customer information letter SY007/18/P advising that corrected values modified in the report are not save. Software patch VB20A_HF05 is being released to resolve the matter

Recalling firm

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

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2018-03-27
Posted by FDA: 2018-05-09
Terminated: 2020-06-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163815. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.