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Terminated

Syngo.Via VB20A model 1049610

FDA Recall Z-1778-2018 · Posted 2018-05-09

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2018-03-27
Date Terminated2020-06-15

Reason for Recall

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.

Firm Action

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

Root Cause

Software design

Distribution Pattern

Nationwide

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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