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Terminated

Syngo.via systems with SW VB20A

FDA Recall Z-0808-2018 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2017-08-31
Date Terminated2018-10-01
Product Quantity30

Reason for Recall

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.

Firm Action

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).

Root Cause

Software Design Change

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123375SYNGO.VIASiemens AG · 2012-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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