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Terminated

Syngo.via. Medical Device Software. Picture archiving and communications system.

FDA Recall Z-1303-2018 · Posted 2018-03-20

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2018-01-08
Date Terminated2020-04-22
Product Quantity236 units

Reason for Recall

A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.

Firm Action

Customer Advisory Notice SY065/17/P was sent to direct accounts. Firm is continuing to work on software solution. A workaround is available and is described in the Customer Advisory Notice.

Root Cause

Software design

Distribution Pattern

Device is software only. No products are distributed to wholesale dealers, distributers or retailers

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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